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1 845 2701 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
GPT
Kinetic
Monoreagent application
WL1 340
Units U/l
Temperature 37
Factor 1745
N of Read 5
Interval 30
Delay 120
Lim Abs 0.7 min
Lin. Limit 250
Norm High 41
Norm Low 0
Decimals 0
Sample Vol 50
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 50 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 1 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
ALAT(GPT) FS (IFCC mod.) Order information
Cat. No. 1 2701 .. .. …
Notes
1. Please refer to the package insert for ALAT(GPT) FS (IFCC
mod.) for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
2 845 0220 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
ALBU
EP
WL1 630
WL2 546
Units g/dl
Temperature 37
Std 5.0
Factor
Lin. Limit 6.0
Norm High 5.2
Norm Low 3.5
Decimals 1
Sample Vol 5
Reagent Vol 500
Reac. Time 180
MC15
Procedure:
Reagent ready to use
See package insert for reagent stability
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 5 minutes.
Go into programme no. 3 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
ALBUMIN FS Order information
Cat. No. 1 0220 .. .. …
Notes
1. Please refer to the package insert for Albumin FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
3 845 0242 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
MALB
Multi Std - Differential
WL1 405
WL2
Units mg/l
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Alb U/CSF
Point 3 / Conc *Level 2 TruCal Alb U/CSF
Point 4 / Conc *Level 3 TruCal Alb U/CSF
Point 5 / Conc *Level 4 TruCal Alb U/CSF
Point 6 / Conc *Level 5 TruCal Alb U/CSF
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 333
Norm High 20
Norm Low 0
Decimals 1
Sample Vol 20
Reagent Vol 400 + 80
Delay 0
Reac. Time 180
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the programme no. 31. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
ALBUMIN IN URINE/CSF FS (Microalbumin)
Urine/CSF application
Order information
Cat. No. 1 0242 .. .. …
Notes
1. Please refer to the package insert for Albumin in Urine/CSF
FS *Microalbumin for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
4 845 0401 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
ALP
Kinetic
Monoreagent Application
WL1 405
Units U/l
Temperature 37
Factor 2757
N of Read 5
Interval 30
Delay 60
Lim Abs 1.5 max
Lin. Limit 700
Norm High 258
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light! Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 10 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 4 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
ALKALINE PHOSPHATASE FS DGKC
Order information
Cat. No. 1 0401 .. .. …
Notes
1. Please refer to the package insert for
Alkaline phosphatase FS DGKC for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
5 845 0411 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
ALP
Kinetic
Monoreagent Application
WL1 405
Units U/l
Temperature 37
Factor 2757
N of Read 5
Interval 30
Delay 60
Lim Abs 1.5 max
Lin. Limit 700
Norm High 128
Norm Low 42
Decimals 0
Sample Vol 10
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 10 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 5 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
ALKALINE PHOSPHATASE FS IFCC 37° C
Order information
Cat. No. 1 0441 .. .. …
Notes
1. Please refer to the package insert for
Alkaline phosphatase FS IFCC for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
6 845 0501 10 02 71
September 2007/4
StarDust MC15 Chemistry parameters
AMYL
Kinetic
Monoreagent Application
WL1 405
Units U/l
Temperature 37
Factor 4554
N of Read 4
Interval 60
Delay 120
Lim Abs 1.4 Max
Lin. Limit 1800
Norm High 100
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 6 MONTHS AT 2 - 8° C 4 WEEKS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 10 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 6 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
-AMYLASE CC FS Order information
Cat. No. 1 0501 .. .. …
Notes
1. Please refer to the package insert for -Amylase CC FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
7 845 7102 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
APOA
Multi Std – Differential
WL1 578
WL2
Units mg/dl
Number of standards 3
Point 1/ Conc *
Point 2/ Conc *
Point 3/ Conc *
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 250
Norm High 190
Norm Low 110
Decimals 1
Sample Vol 20**
Reagent Vol 400 + 80
Delay 30
Reac. Time 180
*Input by user
MC15
Procedure:
Reagents are ready to use
**Samples/Standards are pre-diluted 1+5 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the Apo A1 programme no. 32. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
APOLIPOPROTEIN A1 FS Order information
Cat. No. 1 7102 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein A1 FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
8 845 7112 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
APOB
Multi Std - Differential
WL1 340
WL2
Units mg/dl
Number of standards 3
Point 1/ Conc *
Point 2/ Conc *
Point 3/ Conc *
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 250
Norm High 155
Norm Low 75
Decimals 1
Sample Vol 20**
Reagent Vol 400 + 80
Delay 30
Reac. Time 180
*Input by user
MC15
Procedure:
Reagents are ready to use
**SamplesStandards are pre-diluted 1+5 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the Apo B programme no. 33. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
APOLIPOPROTEIN B FS Order information
Cat. No. 1 7112 .. .. …
Notes
1. Please refer to the package insert for Apoliporotein B FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
9 845 2601 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
GOT
Kinetic
Monoreagent Application
WL1 340
Units U/l
Temperature 37
Factor 1745
N of Read 5
Interval 30
Delay 120
Lim Abs 0.7 min
Lin. Limit 250
Norm High 37
Norm Low 0
Decimals 0
Sample Vol 50
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 50 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 2 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
ASAT(GOT) FS (IFCC mod.) Order information
Cat. No. 1 2601 .. .. …
Notes
1. Please refer to the package insert for
ASAT(GOT) FS (IFCC Mod) for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
10 845 7012 10 02 71
May 2008/5
StarDust MC15 Chemistry parameters
ASO
Multi Std - FxT
WL1 546
WL2
Units IU/ml
Number of standards 5
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal ASO
Point 3 / Conc *Level 2 TruCal ASO
Point 4 / Conc *Level 3 TruCal ASO
Point 5 / Conc *Level 4 TruCal ASO
Point 6 / Conc
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 400
Norm High 200
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 400 + 80
Delay 30
Reac. Time 180
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 10 µl
Samples 400 µl 10 µl
Place the cuvette strip in the incubating position for 5 minutes
Go into the programme no. 34. Input the number of samples and the initial position for them and whether a recalibration is needed.
Add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip immediately in the reading position and press READ
ANTISTREPTOLYSIN O FS Order information
Cat. No. 1 7012 .. .. …
Notes
1. Please refer to the package insert for Antistreptolysin O FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
11 845 0950 10 02 71
May 2008/5
StarDust MC15 Chemistry parameters
CO2
FxT
WL1 405
Units mmol/l
Temperature 37
Std 30
Factor
Interval 390
Delay 30
Lim Abs Min 0
Lin. Limit 50
Norm High 29
Norm Low 22
Decimals 1
Sample Vol 5
Reagent Vol 500
MC15
Procedure:
Reagent ready to use
See package insert for reagent stability
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Go into the programme no. 35. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
BICARBONATE FS Order information
Cat. No. 1 0950 .. .. …
Notes
1. Please refer to the package insert for Bicarbonate FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
12 845 0821 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
BILD
Diff
WL1 546
WL2 630
Units mg/dl
Temperature 37
Std 2.62
Factor
Lin. Limit 10.0
Norm High 0.2
Norm Low 0.0
Decimals 2
Sample Vol 50
Reagent Vol 400 + 100
Delay 0
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 50 µl
Samples 400 µl 50 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 7 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
BILIRUBIN AUTO DIRECT FS Order information
Cat. No. 1 0821 .. .. …
Notes
1. Please refer to the package insert for Bilirubin Auto Direct FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
13 845 0811 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
BILT
Diff
WL1 546
WL2 630
Units mg/dl
Temperature 37
Std 4.47
Factor
Lin. Limit 10.0
Norm High 1.2
Norm Low 0.1
Decimals 1
Sample Vol 50
Reagent Vol * 400 + 100
Delay 0
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 50 µl
Samples 400 µl 50 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 8 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
BILIRUBIN AUTO TOTAL FS
Order information
Cat. No. 1 0811 .. .. …
Notes
1. Please refer to the package insert for Bilirubin Auto Total
FS for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
14 845 1802 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
C3
Multi Std - Differential
WL1 340
WL2
Units mg/dl
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Protein
Point 3 / Conc *Level 2 TruCal Protein
Point 4 / Conc *Level 3 TruCal Protein
Point 5 / Conc *Level 4 TruCal Protein
Point 6 / Conc *Level 5 TruCal Protein
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 400
Norm High 180
Norm Low 90
Decimals 0
Sample Vol 10
Reagent Vol 500 + 100
Delay 0
Reac. Time 300
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 500 µl
Stds (Optional) 500 µl 10 µl
Samples 500 µl 10 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the programme no. 36. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
COMPLEMENT C3c FS
Order information
Cat. No. 1 1802 .. .. …
Notes
1. Please refer to the package insert for Complement C3c FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany d.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
15 845 1812 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
C4
Multi Std - Differential
WL1 340
WL2
Units mg/dl
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Protein
Point 3 / Conc *Level 2 TruCal Protein
Point 4 / Conc *Level 3 TruCal Protein
Point 5 / Conc *Level 4 TruCal Protein
Point 6 / Conc *Level 5 TruCal Protein
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 90
Norm High 40
Norm Low 10
Decimals 0
Sample Vol 10
Reagent Vol 400 + 80
Delay 0
Reac. Time 300
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 10 µl
Samples 400 µl 10 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the programme no. 37. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
COMPLEMENT C4 FS
Order information
Cat. No. 1 1812 .. .. …
Notes
1. Please refer to the package insert for Complement C4 FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
16 845 1130 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
CALC
EP
WL1 670
WL2 578
Units mg/dl
Temperature 37
Std 10.0
Factor
Lin. Limit 25.0
Norm High 10.3
Norm Low 8.6
Decimals 1
Sample Vol 10
Reagent Vol 500
Reac. Time 600
MC15
Procedure:
Reagent ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 5 minutes.
Go into programme no. 9 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
CALCIUM AS FS Order information
Cat. No. 1 1130 .. .. …
Notes
1. Please refer to the package insert for Calcium AS FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
18 845 1181 10 02 71
September 2009/5
StarDust MC15 Chemistry parameters
CALC
Diff
WL1 670
WL2 546
Units mg/dl
Temperature 37
Std 10.0
Factor
Lin. Limit 25.0
Norm High 10.3
Norm Low 8.6
Decimals 1
Sample Vol 5
Reagent Vol 400 + 100
Delay 180
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl
Samples 400 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 38 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
CALCIUM P FS Order information
Cat. No. 1 1181 .. .. …
Notes
1. Please refer to the package insert for Calcium P FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
19 845 1401 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
CLIN
Kinetic
WL1 405
Units U/l
Temperature 37
Factor 55016
N of Read 4
Interval 60
Delay 120
Lim Abs 0.1 min
Lin. Limit 25000
Norm High 11500
Norm Low 3930
Decimals 0
Sample Vol 10
Reagent Vol 400 + 100
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 10 µl
Samples 400 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position and leave it for 3 minutes at 37°C
Go into the programme no. 39. Input the number of samples and the initial position for them.
Take out the cuvette strip out of the incubating position and add 100 µl R2 to all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CHOLINESTERASE FS Order information
Cat. No. 1 1401 .. .. …
Notes
1. Please refer to the package insert for Cholinesterase FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
20 845 1200 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
CL
EP
WL1 500
WL2 630
Units mmol/l
Temperature 37
Std 100
Factor
Lin. Limit 130
Norm High 108
Norm Low 96
Decimals 0
Sample Vol 5
Reagent Vol 500
Reac. Time 180
MC15
Procedure:
Reagent ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 3 minutes.
Go into programme no. 11 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
CHLORIDE FS Order information
Cat. No. 1 1200 .. .. …
Notes
1. Please refer to the package insert for Chloride FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
21 845 1300 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
CHOL
EP
WL1 500
WL2 630
Units mg/dl
Temperature 37
Std 200
Factor
Lin. Limit 380
Norm High 200
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 500
Reac. Time 600
MC15
Procedure:
Reagent ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 10 minutes.
Go into programme no. 12 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
CHOLESTEROL FS Order information
Cat. No. 1 1300 .. .. …
Notes
1. Please refer to the package insert for Cholesterol FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
22 845 1651 10 02 71
May 2008/2
StarDust MC15 Chemistry parameters
CK-M
Kinetic
Substrate start DS
WL1 340
Units U/l
Temperature 37
Factor 4127
N of Read 4
Interval 60
Delay 180
Lim Abs 1.4 max
Lin. Limit 1000
Norm High 24
Norm Low 0
Decimals 0
Sample Vol 20
Reagent Vol 400 + 100
MC15
Procedure:
Reagent 1: Mix 1 part of CK-MB DS with 20 parts R1. STABILITY: 6 days at 2 – 8 ° C 24 hrs at 15 – 25 ° C
Reagent 2: R2 is ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 20 µl
Samples 400 µl 20 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position and leave it for 15 minutes at 37°C
Go into the programme no. 40. Input the number of samples and the initial position for them.
Take out the cuvette strip out of the incubating position and add 100 µl R2 to all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CK-MB FS Substrate start with DS
Order information
Cat. No. 1 1651 .. .. …
Notes
1. Please refer to the package insert for CK-MB FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
23 845 1651 10 02 71
January 2008/3
StarDust MC15 Chemistry parameters
CK-M
Kinetic
Monoreagent Application
WL1 340
Units U/l
Temperature 37
Factor 8254
N of Read 4
Interval 60
Delay 300
Lim Abs 1.4 Max
Lin. Limit 1000
Norm High 24
Norm Low 0
Decimals 1
Sample Vol 20
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 2 WEEKS AT 2 - 8° C 24 HOURS AT 15 - 25° C The Monoreagent must be protected from light!
A free initial cuvette position must be left to perform the optical zero (blank). Pipette 500 µl of reagent into the reagent position in the cuvette strips.
Place the cuvette strip in the incubating position and leave it for 15 minutes at 37°C
Pipette 20 µl sample into the sample position Incubate for a further 2 – 3 minutes at 37°C Go into programme no. 13 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CK-MB FS Order information
Cat. No. 1 1651 .. .. …
Notes
1. Please refer to the package insert for CK-MB FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at
least one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
24 845 1601 10 02 71
January 2008/3
StarDust MC15 Chemistry parameters
CK-N
Kinetic
Monoreagent Application
WL1 340
Units U/l
Temperature 37
Factor 4127
N of Read 4
Interval 60
Delay 180
Lim Abs 1.4 Max
Lin. Limit 1000
Norm High 195
Norm Low 24
Decimals 0
Sample Vol 20
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 3 WEEKS AT 2 - 8° C 2 DAYS AT 15 - 25° C The Monoreagent must be protected from light!
A free initial cuvette position must be left to perform the optical zero (blank). Pipette 500 µl of reagent into the reagent position in the cuvette strips.
Place the cuvette strip in the incubating position and leave it for 15 minutes at 37°C
Pipette 20 µl sample into the sample position Incubate for a further 2 – 3 minutes at 37°C Go into programme no. 14 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CK-NAC FS
Order information
Cat. No. 1 1601 .. .. …
Notes
1. Please refer to the package insert for CK-NAC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. The stability of the reagent on board the analyser is at
least one month provided that contamination and evaporation are avoided.
3. Manufactured by
DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
26 845 1759 10 02 71
May 2008/5
StarDust MC15 Chemistry parameters
CREA
Diff
WL1 546
WL2 630
Units mg/dl
Temperature 37
Std 2.0
Factor
Lin. Limit 30
Norm High 1.3
Norm Low 0.5
Decimals 2
Sample Vol 10
Reagent Vol 400 + 200
Delay 180
Reac Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 10 µl
Samples 400 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 42 . Input the number of samples and the initial position for them and whether a recalibration is needed
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 200 µl R2 to all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CREATININE PAP FS Order information
Cat. No. 1 1759 .. .. …
Notes
1. Please refer to the package insert for Creatinine PAP FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
26 845 1759 10 02 71
April 2011/6
StarDust MC15 Chemistry parameters
CREA
Diff
WL1 546
WL2 630
Units mg/dl
Temperature 37
Std 2.0
Factor
Lin. Limit 160
Norm High 1.3
Norm Low 0.5
Decimals 2
Sample Vol 10
Reagent Vol 400 + 200
Delay 180
Reac Time 300
MC15
Procedu re:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 400 µl Std (Optional) 400 µl 10 µl Samples 400 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 42 . Input the number of samples and the initial position for them and whether a recalibration is needed
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 200 µl R2 to all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CREATININE PAP FS Order information Cat. No. 1 1759 .. .. …
Notes 1. Please refer to the package insert for Creatinine PAP FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized b y it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has sub sequently been tested at a variety of customer laboratories a nd validated by use.
25 845 1711 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
CREA
FxT
Monoreagent application
WL1 500
Units mg/dl
Temperature 37
Std 2.0
Factor
Interval 120
Delay 30
Lim Abs Max 2.5
Lin. Limit 7.5
Norm High 1.3
Norm Low 0.6
Decimals 1
Sample Vol 50
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 5 HOURS AT 15 – 25 °C
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 50 µl
Samples 500 µl 50 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 15 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CREATININE FS Order information
Cat. No. 1 1711 .. .. …
Notes
1. Please refer to the package insert for Creatinine FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
28 845 7045 10 42 71
May 2008/4
StarDust MC15 Chemistry parameters
CRP
Multi Std - FxT
WL1 500
WL2
Units mg/l
Number of standards 6
Point 1/ Conc NaCl – 0
Point 2 / Conc *Level 1 TruCal CRP hs
Point 3 / Conc *Level 2 TruCal CRP hs
Point 4 / Conc *Level 3 TruCal CRP hs
Point 5 / Conc *Level 4 TruCal CRP hs
Point 6 / Conc *Level 5 TruCal CRP hs
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 20
Norm High 5
Norm Low 0
Decimals 2
Sample Vol 20
Reagent Vol 200 + 200
Delay 60
Interval 240
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1+2 (Reading zone)
Sample (Sample zone)
Blank 200 µl + 200 µl
Stds (Optional) 200 µl + 200 µl 20 µl
Samples 200 µl + 200 ml 20 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into the programme no. 44. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CRP U-hs High sensitive (hs) application
Order information Cat. No. 1 7045 .. .. …
Notes
1. Please refer to the package insert for CRP U-hs FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
27 845 7002 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
CRP
Multi Std - Differential
WL1 340
WL2
Units mg/l
Number of standards 5
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal CRP
Point 3 / Conc *Level 2 TruCal CRP
Point 4 / Conc *Level 3 TruCal CRP
Point 5 / Conc *Level 4 TruCal CRP
Point 6 / Conc *Level 5 TruCal CRP
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 280
Norm High 5
Norm Low 0
Decimals 0
Sample Vol 20
Reagent Vol 400 + 80
Delay 0
Reac. Time 180
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the programme no. 43. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
CRP FS Order information
Cat. No. 1 7002 .. .. …
Notes
1. Please refer to the package insert for CRP FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
845 7268 10 02 71
October 2008/1
StarDust MC15 Chemistry parameters
DMER
Multi Std - FxT
WL1 578
WL2
Units µg/ml
Number of standards 6
Point 1/ Conc Level 1 Diluent
Point 2 / Conc *Level 2
Point 3 / Conc *Level 3
Point 4 / Conc *Level 4
Point 5 / Conc *Level 4
Point 6 / Conc *Level 6
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 8.7
Norm High 0.5
Norm Low 0
Decimals 2
Sample Vol 10
Reagent Vol 300 + 100
Delay 30
Reac. Time 180
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 300 µl
Stds (Optional) 300 µl 10 µl
Samples 300 µl 10 µl
Place the cuvette strip in the incubating position for 5 minutes
Go into the programme no. X. Input the number of samples and the initial position for them and whether a recalibration is needed.
Add 100 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip immediately in the reading position and press READ
D-DIMER FS Order information
Cat. No. 1 7268 .. .. …
Notes
1. Please refer to the package insert for D-Dimer FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
30 845 1360 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
FCHO
EP
WL1 500
WL2 630
Units mg/dl
Temperature 37
Std 200
Factor
Lin. Limit 250
Norm High 200
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 500
Reac. Time 600
MC15
Procedure:
Reagent ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 10 minutes.
Go into programme no. 46 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
FREE CHOLESTEROL FS Order information
Cat. No. 1 1360 .. .. …
Notes
1. Please refer to the package insert for Free Cholesterol FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
31 45 7059 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
FERR
Multi Std - FxT
WL1 578
WL2
Units ng/ml
Number of standards 5
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Ferritin
Point 3 / Conc *Level 2 TruCal Ferritin
Point 4 / Conc *Level 3 TruCal Ferritin
Point 5 / Conc *Level 4 TruCal Ferritin
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 1000
Norm High 300
Norm Low 30
Decimals 1
Sample Vol 10
Reagent Vol 200 + 100
Delay 30
Interval 180
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1+2 (Reading zone)
Sample (Sample zone)
Blank 200 µl + 100 µl
Stds (Optional) 200 µl + 100 µl 10 µl
Samples 200 µl + 100 ml 10 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into the programme no. 47. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
FERRITIN FS Order information
Cat. No. 1 7059 .. .. …
Notes
1. Please refer to the package insert for Ferritin FS for
detailed information about the test on the following
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
33 845 2801 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
GGT
Kinetic
Monoreagent Application
WL1 405
Units U/l
Temperature 37
Factor 1309
N of Read 4
Interval 60
Delay 60
Lim Abs 1.500 max
Lin. Limit 230
Norm High 55
Norm Low 0
Decimals 0
Sample Vol 50
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 50 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 17 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
GAMMA GT FS (IFCC stand) Order information
Cat. No. 1 2801 .. .. …
Notes
1. Please refer to the package insert for Gamma-GT FS (Szasz
mod./ IFCC stand) for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
34 845 2801 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
GGT
Kinetic
Monoreagent Application
WL1 405
Units U/l
Temperature 37
Factor 1158
N of Read 4
Interval 60
Delay 60
Lim Abs 1.500 max
Lin. Limit 230
Norm High 49
Norm Low 0
Decimals 0
Sample Vol 50
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 50 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 16 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
GAMMA GT FS (Szasz mod.) Order information
Cat. No. 1 2801 .. .. …
Notes
1. Please refer to the package insert for Gamma-GT FS (Szasz
mod./ IFCC stand) for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
35 845 2411 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
GLDH
Kinetic
WL1 340
Units U/l
Temperature 37
Factor 1485
N of Read 4
Interval 60
Delay 30
Lim Abs 0.3 min
Lin. Limit 120
Norm High 7
Norm Low 0
Decimals 1
Sample Vol 50
Reagent Vol 400 + 100
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 50 µl
Samples 400 µl 50 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position and leave it for 3 minutes at 37°C
Go into the programme no. 49. Input the number of samples and the initial position for them and whether a recalibration is needed.
Take out the cuvette strip out of the incubating position and add 100 µl R2 to all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
GLDH FS DGKC
Order information
Cat. No. 1 2411 .. .. …
Notes
1. Please refer to the package insert for GLDH FS DGKC for
the detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection
Precision (Reproducibility, Repeatability) Method Comparison Reference Ranges Literature 2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
36 845 2500 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
GLUC
EP
WL1 500
WL2 630
Units mg/dl
Temperature 37
Std 100
Factor
Lin. Limit 400
Norm High 115
Norm Low 70
Decimals 0
Sample Vol 5
Reagent Vol 500
Reac. Time 600
MC15
Procedure:
Reagent ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 10 minutes.
Go into programme no. 18 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
GLUCOSE GOD FS Order information
Cat. No. 1 2500 .. .. …
Notes
1. Please refer to the package insert for Glucose GOD FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
37 845 2511 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
GLUC
EP
Monoreagent application
WL1 340
WL2 630
Units mg/dl
Temperature 37
Std 100
Factor
Lin. Limit 500
Norm High 115
Norm Low 70
Decimals 0
Sample Vol 5
Reagent Vol 500
Reac. Time 300
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 3 MONTHS AT 2 - 8° C 2 WEEKS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 5 minutes.
Go into programme no. 19 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
GLUCOSE HEXOKINASE FS
Order information
Cat. No. 1 2511 .. .. …
Notes
1. Please refer to the package insert for Glucose Hexokinase
FS for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
38 845 3329 10 02 71
May 2008/5
StarDust MC15 Chemistry parameters
HBA1
Multi Std - EP
WL1 630
WL2 Select pos 8 ( (empty)
Units %
Number of standards 5
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal HbA1c
Point 3 / Conc *Level 2 TruCal HbA1c
Point 4 / Conc *Level 3 TruCal HbA1c
Point 5 / Conc *Level 4 TruCal HbA1c
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 15
Norm High 6
Norm Low 4
Decimals 2
Sample Vol 10
Reagent Vol 300 + 100 + 50
Reac. Time 240
*Input by user
MC15
Procedure:
Reagents are ready to use
The end point incubation must be switched on before measurement. To do this go to 4: Utilities, option 12: E.P. Incubation, select 1:Y
Pipette into the cuvette strips in the appropriate way.
Pipette 300 µl Reagent 1 (reading zone)
Incubate for 5 minutes in the incubation block
Go into the programme no. 50. Input the number of samples and the initial position for them and whether a recalibration is
needed.
Pipette 10 µl Sample (Sample zone)
Mix and incubate at 37°C for 3 minutes in the incubation block
After 3 min of incubation add 100 µl R2 into the reading zone in the cuvettes
Mix and incubate at 37°C for a further 2 minutes in the incubation block
After 2 min of incubation add 50 µl R3 into the sample zone in the cuvettes
Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
one HbA1c FS 3 Component System
Order information
Cat. No. 1 3329 .. .. …
Notes
1. Please refer to the package insert for oneHbA1c FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
40 845 3521 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
HDL
Diff
WL1 578
WL2 670
Units mg/dl
Temperature 37
Std 99.8
Factor
Lin. Limit 180
Norm High 80
Norm Low 35
Decimals 0
Sample Vol 5
Reagent Vol 400 + 100
Delay 280
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl
Samples 400 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 20 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
HDL-C IMMUNO FS Order information Cat. No. 1 3521 .. .. …
Notes
1. Please refer to the package insert for HDL-C Immuno FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
41 845 7202 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
IGA
Multi Std - Differential
WL1 578
WL2
Units mg/dl
Number of standards 4
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 2 TruCal Protein
Point 3 / Conc *Level 4 TruCal Protein
Point 4 / Conc *Level 5 TruCal Protein
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 900
Norm High 400
Norm Low 70
Decimals 0
Sample Vol 30**
Reagent Vol 400 + 80
Delay 0
Reac. Time 300
*Input by user This application has been prozone tested up to 9200 mg/dl and no ambiguous results were observed.
MC15
Procedure:
Reagents are ready to use
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 30 µl
Samples 400 µl 30 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the IgA programme no. 52. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
IMMUNOGLOBULIN A FS Order information
Cat. No. 1 7202 .. .. …
Notes
1. Please refer to the package insert for Immunoglobulin A FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
42 845 7239 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
IGE
Multi Std - FxT
WL1 578
WL2
Units IU/ml
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal IgE
Point 3 / Conc *Level 2 TruCal IgE
Point 4 / Conc *Level 3 TruCal IgE
Point 5 / Conc *Level 4 TruCal IgE
Point 6 / Conc *Level 5 TruCal IgE
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 1000
Norm High 100
Norm Low 0
Decimals 1
Sample Vol 5
Reagent Vol 200 + 100
Delay 30
Interval 180
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1+2 (Reading zone)
Sample (Sample zone)
Blank 200 µl + 100 µl
Stds (Optional) 200 µl + 100 µl 5 µl
Samples 200 µl + 100 ml 5 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into the programme no. 53. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
IMMUNOGLOBULIN E FS Order information
Cat. No. 1 7239 .. .. …
Notes
1. Please refer to the package insert for Immunoglobulin E FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
43 845 7212 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
IGG
Multi Std - Differential
WL1 578
WL2
Units mg/dl
Number of standards 4
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 2 TruCal Protein
Point 3 / Conc *Level 4 TruCal Protein
Point 4 / Conc *Level 5 TruCal Protein
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 3500
Norm High 1600
Norm Low 700
Decimals 0
Sample Vol 20**
Reagent Vol 400 + 80
Delay 0
Reac. Time 300
*Input by user This application has been prozone tested up to 35000 mg/dl and no ambiguous results were observed.
MC15
Procedure:
Reagents are ready to use
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 20 µl
Samples 400 µl 20 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the IGG programme no. 54. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
IMMUNOGLOBULIN G FS Order information
Cat. No. 1 7212 .. .. …
Notes
1. Please refer to the package insert for Immunoglobulin G FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
44 845 7222 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
IGM
Multi Std - Differential
WL1 340
WL2
Units mg/dl
Number of standards 4
Point 1/ Conc NaCl – 0
Point 2 / Conc *Level 1 TruCal Protein
Point 3 / Conc *Level 3 TruCal Protein
Point 4 / Conc *Level 4 TruCal Protein
Point 5 / Conc *Level 5 TruCal Protein
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 800
Norm High 230
Norm Low 40
Decimals 0
Sample Vol 50**
Reagent Vol 400 + 80
Delay 0
Reac. Time 300
*Input by user This application has been prozone tested up to 5000 mg/dl and no ambiguous results were observed.
MC15
Procedure:
Reagents are ready to use
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 50 µl
Samples 400 µl 50 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the IgM programme no. 55. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
IMMUNOGLOBULIN M FS Order information
Cat. No. 1 7222 .. .. …
Notes
1. Please refer to the package insert for Immunoglobulin M FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
45 845 1911 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
IRON
Diff
WL1 578
WL2
Units µg/dl
Temperature 37
Std 202
Factor
Lin. Limit 270
Norm High 168
Norm Low 23
Decimals 0
Sample Vol 100
Reagent Vol 400 + 100
Delay 0
Reac. Time 600
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 100 µl
Samples 400 µl 100 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 21 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
IRON FS Ferene Order information
Cat. No. 1 1911 .. .. …
Notes
1. Please refer to the package insert for Iron FS Ferene for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
46 845 4001 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
LACT
Diff
WL1 340
WL2 0
Units mg/dl
Temperature 37
Std *
Factor
Lin. Limit 120.0
Norm High 19.8
Norm Low 4.5
Decimals 1
Sample Vol 5
Reagent Vol * 400 + 100
Delay 180
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl
Samples 400 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 57. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
LACTATE FS Order information
Cat. No. 1 4001 .. .. …
Notes
1. Please refer to the package insert for Lactate FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
47 845 4201 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
LDH
Kinetic
Monoreagent application
WL1 340
Units U/l
Temperature 37
Factor 8095
N of Read 5
Interval 30
Delay 60
Lim Abs 0.700 min
Lin. Limit 2400
Norm High 480
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 5 DAYS AT 2 - 8° C 8 HOURS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 10 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 22 . Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
LDH FS DGKC Order information
Cat. No. 1 4201 .. .. …
Notes
1. Please refer to the package insert for LDH.FS DGKC for
the detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
48 845 4211 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
LDH
Kinetic
Monoreagent application
WL1 340
Units U/l
Temperature 37
Factor 8095
N of Read 5
Interval 30
Delay 60
Lim Abs 0.900 max
Lin. Limit 1500
Norm High 248
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 24 HOURS AT 2 - 8° C 4 HOURS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way. A free initial cuvette position must be left to perform the optical zero (blank)
Reagent (Reading zone)
Sample (Sample zone)
Samples 500 µl 10 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 30. Input the number of samples and the initial position for them.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
LDH FS IFCC Order information
Cat. No. 1 4211 .. .. …
Notes
1. Please refer to the package insert for LDH FS IFCC for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
49 845 4121 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
LDL
Diff
WL1 578
WL2 670
Units mg/dl
Temperature 37
Std *
Factor
Lin. Limit 400
Norm High 130
Norm Low 0
Decimals 0
Sample Vol 5
Reagent Vol 400 + 100
Delay 280
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 5 µl
Samples 400 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 58 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
LDL-C SELECT FS Order information
Cat. No. 1 4121 .. .. …
Notes
1. Please refer to the package insert for LDL-C Select FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
50 845 4321 10 02 71
May 2008/5
StarDust MC15 Chemistry parameters
LIPA
Kin
WL1 578
Units U/l
Temperature 37
Std Input value
Factor
N of Read 3
Interval 60
Delay 120
Lin. Limit 240
Norm High 60
Norm Low 0
Decimals 1
Sample Vol 10
Reagent Vol 400 + 100
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 10 µl
Samples 400 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position and leave it for 3 minutes at 37°C
Go into the programme no. 59. Input the number of samples and the initial position for them and whether a recalibration is needed.
Take out the cuvette strip out of the incubating position and add 100 µl R2 to all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
LIPASE DC FS Order information
Cat. No. 1 4321 .. .. …
Notes
1. Please refer to the package insert for Lipase DC FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
51 845 7139 10 02 71
May 2008/3
StarDust MC15 Chemistry parameters
LPA
Multi Std - FxT
WL1 670
WL2
Units mg/dl
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Lp(a) 21
Point 3 / Conc *Level 2 TruCal Lp(a) 21
Point 4 / Conc *Level 3 TruCal Lp(a) 21
Point 5 / Conc *Level 4 TruCal Lp(a) 21
Point 6 / Conc *Level 5 TruCal Lp(a) 21
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 130
Norm High 30
Norm Low 0
Decimals 1
Sample Vol 10
Reagent Vol 400 + 200
Delay 30
Interval 300
*Input by user
MC15
Procedure:
Reagents are ready to use
Premix 2 parts R1 with 1 part R2 making sufficient for the number of tests
Pipette into the cuvette strips in the appropriate way.
Reagent 1+2 premixed
(Reading zone)
Sample (Sample zone)
Blank 600 µl
Stds (Optional) 600 µl 10 µl
Samples 600 µl 10 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into the programme no. 60. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
Lp(a) 21 FS Order information
Cat. No. 1 7139 .. .. …
Notes
1. Please refer to the package insert for Lp(a) 21 FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
52 845 4610 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
MAG
EP
WL1 546
WL2 670
Units mg/dl
Temperature 37
Std 2.00
Factor
Lin. Limit 5.00
Norm High 2.6
Norm Low 1.8
Decimals 2
Sample Vol 5
Reagent Vol 500
Reac. Time 180
MC15
Procedure:
Reagent ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 3 minutes.
Go into programme no. 23 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
MAGNESIUM XL FS Order information
Cat. No. 1 4610 .. .. …
Notes
1. Please refer to the package insert for Magnesium XL FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
55 845 5211 10 02 71
May 2008/5
StarDust MC15 Chemistry parameters
PHOS
EP
Monoreagent application
WL1 340
WL2 630
Units mg/dl
Temperature 37
Std 5.0
Factor
Lin. Limit 30.0
Norm High 4.5
Norm Low 2.6
Decimals 1
Sample Vol 5
Reagent Vol 500
Reac. Time 300
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 1 YEAR AT 2 – 8° C
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 5 minutes.
Go into programme no. 24 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
PHOSPHATE FS Order information
Cat. No. 1 5211 .. .. …
Notes
1. Please refer to the package insert for Phosphate FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
56 845 7022 10 02 71
May 2008/6
StarDust MC15 Chemistry parameters
RF
Multi Std - Differential
WL1 340
WL2 630
Units IU/ml
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal RF
Point 3 / Conc *Level 2 TruCal RF
Point 4 / Conc *Level 3 TruCal RF
Point 5 / Conc *Level 4 TruCal RF
Point 6 / Conc *Lavel 5 TruCal RF
Readings per standard 1
Readings per sample 1
Temperature 37
Lin. Limit 500
Norm High 15
Norm Low 0
Decimals 1
Sample Vol 25
Reagent Vol 400 + 80
Delay 0
Reac. Time 300
*Input by user
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank (Water) 400 µl
Stds (Optional) 400 µl 25 µl
Samples 400 µl 25 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 15 minutes
Go into the programme no. 63. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
RHEUMATOID FACTOR FS Order information
Cat. No. 1 7022 .. .. …
Notes
1. Please refer to the package insert for Rheumatoid Factor
FS for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
57 845 2311 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
T PR
Diff
WL1 546
WL2 630
Units g/dl
Temperature 37
Std 5.0
Factor
Lin. Limit 15.0
Norm High 8.8
Norm Low 6.6
Decimals 1
Sample Vol 10
Reagent Vol 400 + 100
Delay 0
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 10 µl
Samples 400 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 25 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
TOTAL PROTEIN FS Order information
Cat. No. 1 2311 .. .. …
Notes
1. Please refer to the package insert for Total Protein FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
58 845 0210 10 52 71
May 2008/5
StarDust MC15 Chemistry parameters
URPR
EP
WL1 578
WL2 670
Units mg/l
Temperature 37
Std 1300
Factor
Lin. Limit 3000
Norm High 141
Norm Low 24
Decimals 0
Sample Vol 10
Reagent Vol 500
Reac. Time 300
MC15
Procedure:
Reagent ready to use
See package insert for reagent stability
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 5 minutes.
Go into the programme no. 64. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
TOTAL PROTEIN UC FS Order information
Cat. No. 1 0210 .. .. …
Notes
1. Please refer to the package insert for Total Protein UC FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
59 845 7252 10 02 71
May 2008/4
StarDust MC15 Chemistry parameters
TRAN
Multi Std - Differential
WL1 578
WL2
Units mg/dl
Number of standards 6
Point 1/ Conc NaCl - 0
Point 2 / Conc *Level 1 TruCal Protein
Point 3 / Conc *Level 2 TruCal Protein
Point 4 / Conc *Level 3 TruCal Protein
Point 5 / Conc *Level 4 TruCal Protein
Point 6 / Conc *Level 5 TruCal Protein
Readings per standard 2
Readings per sample 1
Temperature 37
Lin. Limit 800
Norm High 360
Norm Low 200
Decimals 0
Sample Vol 30**
Reagent Vol 400 + 80
Delay 0
Reac. Time 300
*Input by user
MC15
Procedure:
Reagents are ready to use
**Samples/Standards are pre-diluted 1+10 with 0.9% NaCl
Pipette into the cuvette strips in the appropriate way. Samples are dispensed directly into the reading zone
Reagent 1 (Reading zone)
Sample (Reading zone)
Blank 400 µl
Stds (Optional) 400 µl 30 µl
Samples 400 µl 30 µl
Place the cuvette strip in the incubating position for 10 minutes
Go into the programme no. 65. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 80 µl R2 into the sample position in all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
TRANSFERRIN FS Order information
Cat. No. 1 7252 .. .. …
Notes
1. Please refer to the package insert for Transferrin FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
60 845 5710 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
TRIG
EP
WL1 500
WL2 630
Units mg/dl
Temperature 37
Std 200
Factor
Lin. Limit 500
Norm High 200
Norm Low 0
Decimals 0
Sample Vol 10
Reagent Vol 500
Reac. Time 600
MC15
Procedure:
Reagent ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 10 minutes.
Go into programme no. 26 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
TRIGLYCERIDES FS Order information
Cat. No. 1 5710 .. .. …
Notes
1. Please refer to the package insert for Triglycerides FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
61 845 1921 10 02 71
May 2008/2
StarDust MC15 Chemistry parameters
UIBC
Diff
WL1 578
WL2
Units µg/dl
Temperature 37
Std TruCal
Factor
Lin. Limit 750
Norm High 470
Norm Low 120
Decimals 0
Sample Vol 30
Reagent Vol 400 + 100
Delay 300
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 30 µl
Samples 400 µl 30 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 41 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
UIBC FS Order information
Cat. No. 1 1921 .. .. …
Notes
1. Please refer to the package insert for UIBC FS
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
63 845 3115 10 02 71
May 2008/6
StarDust MC15 Chemistry parameters
UREA
EP
WL1 578
WL2 -
Units mg/dl
Temperature 37
Std 50
Factor
Lin. Limit 300
Norm High 43
Norm Low 17
Decimals 1
Sample Vol 5
Reagent Vol * 250 + 250
Delay 0
Reac. Time 300
MC15
Procedure:
Reagents are ready to use. Reagent 1A needs to be prepared as described
Stds/Controls/Samples must be diluted 1+1 with NaCl
Pipette into the cuvette strips in the appropriate way. Please note samples must be dispensed directly into the reading zone
Reagent 1A (Reading zone)
Sample (Reading zone)
Blank 250 µl
Std (Optional) 250 µl 5 µl
Samples 250 µl 5 µl
Incubate for 10 mins at room temperature or 5 mins at 37°C
When the incubation is completed take out the cuvette strip and add 250 µl R2 to all the cuvettes
Place the cuvette strip in the mixing position and press MIX
Incubate for 10 mins at room temperature or 5 mins at 37°C
Go into the programme no 66. Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
UREA CT FS Order information
Cat. No. 1 3115 .. .. …
Notes
1. Please refer to the package insert for Urea CT FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
62 845 3101 10 02 71
September 2007/4
StarDust MC15 Chemistry parameters
UREA
FxT
Monoreagent application
WL1 340
Units mg/dl
Temperature 37
Std 50
Factor
Interval 60
Delay 30
Lim. Abs. 0.5 MAX
Lin. Limit 300
Norm High 43
Norm Low 17
Decimals 0
Sample Vol 5
Reagent Vol 500
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 4 WEEKS AT 2 - 8° C 5 DAYS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 5 µl
Samples 500 µl 5 µl
Place the cuvette strip in the incubating position and leave it for 5 minutes at 37°C
Go into programme no. 27 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the reading position and press READ
UREA FS Order information
Cat. No. 1 3101 .. .. …
Notes
1. Please refer to the package insert for Urea FS for detailed
information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
64 845 3021 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
URIC
EP
Monoreagent application
WL1 546
WL2 630
Units mg/dl
Temperature 37
Std 6.0
Factor
Lin. Limit 20.0
Norm High 8.2
Norm Low 2.3
Decimals 1
Sample Vol 10
Reagent Vol 500
Reac. Time 600
MC15
Procedure:
For Monoreagent mix 4 parts R1 + 1 part R2
STABILITY: 3 MONTHS AT 2 - 8° C 2 WEEKS AT 15 - 25° C The Monoreagent must be protected from light!
Pipette into the cuvette strips in the appropriate way.
Reagent (Reading zone)
Sample (Sample zone)
Blank 500 µl
Std (Optional) 500 µl 10 µl
Samples 500 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Place the cuvette strip in the incubating position for 10 minutes.
Go into programme no. 28 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
URIC ACID FS TBHBA Order information
Cat. No. 1 3021 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS TBHBA
for detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.
65 845 3001 10 02 71
September 2007/3
StarDust MC15 Chemistry parameters
URIC
Diff
WL1 546
WL2
Units mg/dl
Temperature 37
Std 6.0
Factor
Lin. Limit 20.0
Norm High 8.2
Norm Low 2.3
Decimals 1
Sample Vol 10
Reagent Vol * 400 + 100
Delay 240
Reac. Time 300
MC15
Procedure:
Reagents are ready to use
See package insert for reagent stability
Pipette into the cuvette strips in the appropriate way.
Reagent 1 (Reading zone)
Sample (Sample zone)
Blank 400 µl
Std (Optional) 400 µl 10 µl
Samples 400 µl 10 µl
Place the cuvette strip in the mixing position and press MIX
Go into programme no. 29 . Input the number of samples and the initial position for them and whether a recalibration is needed.
Place the cuvette strip in the reading position and press READ
When the reading is completed Take out the cuvette strip and add 100 µl R2 to all the cuvettes Place the cuvette strip in the mixing position and press MIX Place the cuvette strip in the reading position and press READ
URIC ACID (TOOS) FS Order information
Cat. No. 1 3001 .. .. …
Notes
1. Please refer to the package insert for Uric Acid FS for
detailed information about the test on the following:
Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding
- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison
Reference Ranges Literature
2. Manufactured by
DiaSys Diagnostic Systems, Alte Strasse 9, 65558 Holzheim, Germany.
**The Performance of a StarDust MC15/FC as a semi automated photometer unit is mainly characterized by it´s technical specifications (see manual). Quality of results strongly depends on manual test performance of the user. This application was verified at DiaSys and has subsequently been tested at a variety of customer laboratories and validated by use.