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845 2701 10 02 81 December 2009/3
ALAT(GPT) FS (IFCC Mod.) Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # ALAT DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 450 LOW HIGH LOW HIGH Serum # # # # METHOD IFCC Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 2701 10 02 81 December 2009/3
*input calibrator value # entered by the user
Item Name # ALAT ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 15 MAIN 35 53 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 2.500 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # ALAT Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 450 Urine Plasma CSF Dialysis Other Page : 3
845 0220 10 02 81 August 2007/2
Albumin FS Prestige 24i 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. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # ALB DATA INFORMATION CALIBRATION UNITS g/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 600 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD BCG Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0220 10 02 81 August 2007/2
*input calibrator value # entered by the user
Item Name # ALB ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 24 26 LOW 0.000 REAGENT1 VOL 270 µl SUB HIGH 3.000 REAGENT2 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # ALB Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 6.0 Urine Plasma CSF Dialysis Other Page : 3
845 0242 10 02 81
August 2007/2
Albumin In Urine/CSF FS (Microalbumin) Urine/CSF application Prestige 24i 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. 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.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be
validated and assessed with caution.
*input calibrator value # entered by the user
Item Name # MALB DATA INFORMATION CALIBRATION UNITS mg/l TYPE Spline DECIMALS 1 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 405 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0242 10 02 81
August 2007/2
*input calibrator value # entered by the user
Item Name # MALB ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 10 MAIN 53 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 40 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8400 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # MALB Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 350 Urine Plasma CSF Dialysis Other Page : 3
845 0242 10 02 81
August 2007/2
March 2006/2
PRESTIGE 24i Chemistry parameters
Item Name ALP
Units [U/l] Decimals [0]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [RATE] MainW. Length1 [405] Subw. Length2 [660] Method [IFCC]
N-Range Male and Female [#] – [#]
Reagent Kind [Double] Sample Volume [5 µl] Reagent 1 Volume [200 µl] Reagent 2 Volume [50 µl]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [35] – [54] Sub [ ] – [ ] Absorbance Limit [-3.000] – [3.000] Linear Check [90%] Endpoint Limit [0.000]
Factor: Blank Correction [1.000]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [0] High-SW [Off] Serum [Off] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
ALKALINE PHOSPHATASE FS DGKC Order information Cat. No. Kit size 10 040 021 R1 5 x 20 ml + R2 1 x 25 ml
10 040 022 R1 5 x 80 ml + R2 1 x 100 ml
10 040 023 R1 1 x 800 ml + R2 1 x 200 ml
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. 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
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 0441 10 02 81 July 2007/3
Alkaline Phosphatase FS IFCC 37 °C Prestige 24i 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. The stability of the reagent on board the analyser is 8 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # ALP DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 405 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD IFCC Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0441 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # ALP ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 4 MAIN 35 54 LOW -1.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # ALP Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 850 Urine Plasma CSF Dialysis Other Page : 3
845 0501 10 02 81 July 2007/2
-Amylase CC FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # aAMY DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 405 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0501 10 02 81 July 2007/2
*input calibrator value # entered by the user
Item Name # aAMY ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 4 MAIN 35 52 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # aAMY Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1000 Urine Plasma CSF Dialysis Other Page : 3
845 7102 10 02 81 July 2007/2
Apolipoprotein A1 FS Prestige 24i Order information Cat. No. 1 7102 .. .. … Notes 1. Please refer to the package insert for Apolipoprotein 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # APOA1 DATA INFORMATION CALIBRATION UNITS mg/l TYPE Logit 1 DECIMALS 1 STANDARD #1 * #4 #2 * #5 ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 570 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7102 10 02 81 July 2007/2
*input calibrator value # entered by the user
Item Name # APOA1 ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 250 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.835 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # APOA1 Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 2500 Urine Plasma CSF Dialysis Other Page : 3
845 7112 10 02 81 July 2007/2
Apolipoprotein B FS Prestige 24i Order information Cat. No. 1 7112 .. .. … Notes 1. Please refer to the package insert for Apolipoprotein 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # APOB DATA INFORMATION CALIBRATION UNITS mg/l TYPE Logit 1 DECIMALS 1 STANDARD #1 * #4 #2 * #5 ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7112 10 02 81 July 2007/2
*input calibrator value # entered by the user
Item Name # APOB ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 250 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.835 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # APOB Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 2500 Urine Plasma CSF Dialysis Other Page : 3
845 2601 10 02 81 July 2007/2
ASAT(GOT) FS (IFCC Mod.) Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # ASAT DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 450 LOW HIGH LOW HIGH Serum # # # # METHOD IFCC Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 2601 10 02 81 July 2007/2
*input calibrator value # entered by the user
Item Name # ASAT ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 15 MAIN 35 53 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 2.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # ASAT Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 450 Urine Plasma CSF Dialysis Other Page : 3
845 7012 10 02 81 May 2007/2
Antistreptolysin O Fs Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # ASO DATA INFORMATION CALIBRATION UNITS IU/ml TYPE Logit 2 DECIMALS 1 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 546 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD IT Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7012 10 02 81 May 2007/2
*input calibrator value # entered by the user
Item Name # ASO ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 49 51 LOW 0.000 REAGENT1 VOL 300 µl SUB 35 36 HIGH 3.000 REAGENT2 60 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # ASO Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 800 Urine Plasma CSF Dialysis Other Page : 3
845 0950 10 02 81
April 2009/1
Bicarbonate FS Prestige 24i 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. 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.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
*input calibrator value # entered by the user
Item Name # BIC DATA INFORMATION CALIBRATION UNITS mmol/l TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 405 MALE FEMALE Main W.Length 2 505 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0950 10 02 81
April 2009/1
*input calibrator value # entered by the user
Item Name # BIC ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 270 µl SUB HIGH 3.000 REAGENT2 0 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # BIC Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 50.0 Urine Plasma CSF Dialysis Other Page : 3
August 2008/1
PRESTIGE 24i Chemistry parameters
Item Name BA
Units [mg/dl] Decimals [1]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [END] MainW. Length1 [546] Subw. Length2 [700] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Double] Sample Volume [20 µl] Reagent 1 Volume [250 µl] Reagent 2 Volume [50 µl]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [52] – [54] Sub [30] – [31] Absorbance Limit [-0.100] – [2.000] Linear Check [40%] Endpoint Limit [ ]
Factor: Blank Correction [0.80]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [#] High-SW [Off] Serum [10.0] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
BILE ACIDS Order information Cat. No. Kit size 1 2212 99 90 313 1 x 50 ml Buffer solution Reagent mixture for 5 x 10 ml R1
1 x 10 ml R2
1 x 2 ml Bile Acids Standard Notes 1. Please refer to the package insert Bile Acids 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
**This application proposal is for guidelines only. To
avoid misinterpretation measured results have to be validated and assessed with caution.
845 0821 10 02 81 May 2007/2
Bilirubin Auto Direct FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # DBIL DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 546 MALE FEMALE Main W.Length 2 660 LOW HIGH LOW HIGH Serum # # # # METHOD DCA Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0821 10 02 81 May 2007/2
*input calibrator value # entered by the user
Item Name # DBIL ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 9 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8069 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # DBIL Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 10.0 Urine Plasma CSF Dialysis Other Page : 3
845 0849 99 02 81
August 2008/1
Bilirubin Direct (Jendrassik Grof) Prestige 24i Order information Cat. No. 1 0849 .. .. … Notes 1. Please refer to the package insert for Bilirubin Jendrassik Grof 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.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be
validated and assessed with caution.
*input calibrator value # entered by the user
For Selectra R1 the kit reagent R3 must be used. The stability on board at 15 – 25 °C is 4 weeks For the Selectra monoreagent the kit reagents R1 and R2 and a 0.9% NACl solution must be premixed It is 40 parts NaCl, 4 parts R1 and 1 part R2 For example 4 ml Nacl, 0.4 ml R1, 0.1 ml R2 This is stabile for 2 hours at 15 – 25 °C The kit reagents R3 and R4 are not used
Item Name # DBIL DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 546 MALE FEMALE Main W.Length 2 LOW HIGH LOW HIGH Serum # # # # METHOD JG Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0849 99 02 81
August 2008/1
*input calibrator value # entered by the user
Item Name # DBIL ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 18 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB - - HIGH 2.500 REAGENT2 0 FACTOR ENDPOINT LIMIT 2.500 Third Mix. OFF ON Blk correction 1.0 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # DBIL Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 10.0 Urine Plasma CSF Dialysis Other Page : 3
845 0811 10 02 81 May 2007/2
Bilirubin Auto Total FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # TBIL DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 546 MALE FEMALE Main W.Length 2 660 LOW HIGH LOW HIGH Serum # # # # METHOD DCA Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0811 10 02 81 May 2007/2
*input calibrator value # entered by the user
Item Name # TBIL ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 5 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 2.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8039 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # TBIL Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 30.0 Urine Plasma CSF Dialysis Other Page : 3
845 0849 99 02 81
August 2008/1
Bilirubin Total (Jendrassik Grof) Prestige 24i Order information Cat. No. 1 0849 .. .. … Notes 1. Please refer to the package insert for Bilirubin Jendrassik Grof 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.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be
validated and assessed with caution.
*input calibrator value # entered by the user
For Selectra R1 the kit reagent R3 must be used. The stability on board at 15 – 25 °C is 4 weeks For Selectra R2 (Start reagent) then the kit reagents R1 and R2 must be premixed 4+1 (4 parts R1 + 1 part R2). This is stabile for 2 hours at 15 – 25 °C The kit reagent R4 is not used
Item Name # TBIL DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 546 MALE FEMALE Main W.Length 2 LOW HIGH LOW HIGH Serum # # # # METHOD JG Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 0849 99 02 81
August 2008/1
*input calibrator value # entered by the user
Item Name # TBIL ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 20 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 2.500 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.500 Third Mix. OFF ON Blk correction 0.80 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # TBIL Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 10.0 Urine Plasma CSF Dialysis Other Page : 3
845 1802 10 02 81
July 2009/1
Complement C3c FS Prestige 24i 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. 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.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
*input calibrator value # entered by the user
Item Name # C3 DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Spline DECIMALS 0 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1802 10 02 81
July 2009/1
*input calibrator value # entered by the user
Item Name # C3 ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 53 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 40 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8353 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # C3 Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 500 Urine Plasma CSF Dialysis Other Page : 3
845 1812 10 02 81
July 2009/1
Complement C4 FS Prestige 24i 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. 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.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
*input calibrator value # entered by the user
Item Name # C4 DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Spline DECIMALS 1 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1812 10 02 81
July 2009/1
*input calibrator value # entered by the user
Item Name # C4 ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 6 MAIN 53 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 40 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8373 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # C4 Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 90 Urine Plasma CSF Dialysis Other Page : 3
845 1130 10 02 81 July 2007/3
Calcium AS FS Prestige 24i 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. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # CA DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 660 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD Arsenazo Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1130 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # CA ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 250 µl SUB HIGH 3.000 REAGENT2 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CA Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 25.0 Urine Plasma CSF Dialysis Other Page : 3
845 1181 10 02 81 July 2007/3
Calcium P FS Prestige 24i 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. The stability of the reagent on board the analyser is 8 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # CaP DATA INFORMATION CALIBRATION UNITS mmol/l TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 660 MALE FEMALE Main W.Length 2 800 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1181 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # CaP ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.80237 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CaP Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 6.24 Urine Plasma CSF Dialysis Other Page : 3
845 1401 10 02 81
March 2009/1
Cholinesterase FS Prestige 24i 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. The stability of the reagent on board the analyser is 8 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
*input calibrator value # entered by the user
Item Name # CHE DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 0 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 405 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1401 10 02 81
March 2009/1
*input calibrator value # entered by the user
Item Name # CHE ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 4 MAIN 35 54 LOW -1.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CHE Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 20000 Urine Plasma CSF Dialysis Other Page : 3
June 2006/2
PRESTIGE 24i Chemistry parameters
Item Name CL
Units [mmol/l] Decimals [0]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [END] MainW. Length1 [450] Subw. Length2 [600] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Single] Sample Volume [3 µl] Reagent 1 Volume [250 µl] Reagent 2 Volume [ ]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [46] – [47] Sub [9] – [10 ] Absorbance Limit [-0.100] – [2.000] Linear Check [40%] Endpoint Limit [2.000]
Factor: Blank Correction [1.000]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [0] High-SW [Off] Serum [300] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
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. 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
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 1300 10 02 81 August 2007/2
Cholesterol FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # CHOL DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 505 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD CHOD-PAP Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1300 10 02 81 August 2007/2
*input calibrator value # entered by the user
Item Name # CHOL ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 300 µl SUB HIGH 2.000 REAGENT2 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CHOL Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 750 Urine Plasma CSF Dialysis Other Page : 3
845 1651 10 02 81
February 2008/1
CK-MB FS Prestige 24i 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # CKMB DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1651 10 02 81
February 2008/1
*input calibrator value # entered by the user
Item Name # CKMB ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 10 MAIN 46 54 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 0 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CKMB Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 2000 Urine Plasma CSF Dialysis Other Page : 3
845 1601 10 02 81 May 2008/1
CK-NAC FS Prestige 24i 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # CK DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 405 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1601 10 02 81 May 2008/1
*input calibrator value # entered by the user
Item Name # CK ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 7 MAIN 35 50 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CK Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1400 Urine Plasma CSF Dialysis Other Page : 3
845 1711 10 02 81 March 2008/3
Creatinine FS Prestige 24i 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. The stability of the reagent on board the analyser is 4 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # CREA DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 505 MALE FEMALE Main W.Length 2 570 LOW HIGH LOW HIGH Serum # # # # METHOD Jaffe Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1711 10 02 81 March 2008/3
*input calibrator value # entered by the user
Item Name # CREA ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 15 MAIN 33 44 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CREA Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 12.5 Urine Plasma CSF Dialysis Other Page : 3
845 1711 10 02 81 March 2008/3
Creatinine FS Prestige 24i Compensated Method To use the Creatinine FS Compensated Method on the Prestige 24i the Correlation ’INTER’ must be changed as follows; When the units are mg/dL
Correlation INTER = - 0.3 When the units are µmol/L
Correlation INTER = - 27 Note: Ensure that when using the Creatinine Compensated Method the relevant assigned Calibrator value is selected
*input calibrator value # entered by the user
Item Name # CREA DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 505 MALE FEMALE Main W.Length 2 570 LOW HIGH LOW HIGH Serum # # # # METHOD Jaffe Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + - 0.3 Page : 1
845 1711 10 02 81 March 2008/3
*input calibrator value # entered by the user
Item Name # CREA ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 15 MAIN 33 44 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CREA Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 12.5 Urine Plasma CSF Dialysis Other Page : 3
845 7045 10 02 81
June 2009/3
CRP U-hs High sensitive (hs) application) Prestige 24i Order information Cat. No. 1 7045 .. .. … Notes 1. Please refer to the package insert for CRP U-hs 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.
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be
validated and assessed with caution.
*input calibrator value # entered by the user
Item Name # CRP DATA INFORMATION CALIBRATION UNITS mg/l TYPE Spline DECIMALS 2 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 505 MALE FEMALE Main W.Length 2 800 LOW HIGH LOW HIGH Serum # # # # METHOD Latex Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7045 10 02 81
June 2009/3
*input calibrator value # entered by the user
Item Name # CRP ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 15 MAIN 49 51 LOW 0.000 REAGENT1 VOL 150 µl SUB 35 36 HIGH 3.000 REAGENT2 150 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CRP Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 20.0 Urine Plasma CSF Dialysis Other Page : 3
December 2004/2
PRESTIGE 24i Chemistry parameters
Item Name CRP
Units [mg/l] Decimals [2]
Calibration Type [Spline] 1 [0.0 ] 2 [Cal 1 ] 3 [Cal 2 ] 4 [Cal 3 ] 5 [Cal 4 ] 6 [Cal 5 ]
Method Type [END] MainW. Length1 [505] Subw. Length2 [700] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Double] Sample Volume [3 µl] Reagent 1 Volume [150 µl] Reagent 2 Volume [150 µl]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [42] – [52] Sub [ ] – [ ] Absorbance Limit [-0.100] – [2.500] Linear Check [10%] Endpoint Limit [ ]
Factor: Blank Correction [1.000]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [#] High-SW [Off] Serum [#] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
CRP U-HS Universal (U) application
Order information Cat. No. Kit size 1 7045 99 10 730 R1 3 x 20 ml + R2 3 x 20 ml Calibrator set for high sensitive (hs) range (5 levels) 1 7040 99 10 059 5 x 1 ml TruCal CRP U
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. 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
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 7002 10 02 81 July 2007/2
CRP FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # CRP DATA INFORMATION CALIBRATION UNITS mg/l TYPE Logit 2 DECIMALS 1 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7002 10 02 81 July 2007/2
*input calibrator value # entered by the user
Item Name # CRP ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 12 MAIN 53 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 40 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8413 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # CRP Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 300 Urine Plasma CSF Dialysis Other Page : 3
845 7059 10 02 81 August 2007/2
Ferritin FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # Ferr DATA INFORMATION CALIBRATION UNITS µg/l TYPE Spline DECIMALS 1 STANDARD #1 * #4 * #2 * #5 ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 570 MALE FEMALE Main W.Length 2 800 LOW HIGH LOW HIGH Serum # # # # METHOD LATEX Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7059 10 02 81 August 2007/2
*input calibrator value # entered by the user
Item Name # Ferr ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 10.5 MAIN 53 54 LOW 0.000 REAGENT1 VOL 210 µl SUB 33 34 HIGH 3.000 REAGENT2 105 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1.000 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # Ferr Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1000 Urine Plasma CSF Dialysis Other Page : 3
845 2801 10 02 81 May 2007/2
Gamma GT FS (Szasz mod./IFCC stand.) Prestige 24i Order information Cat. No. 1 2801 .. .. … Notes 1. Please refer to the package insert for Gamma-GT FS (Szasz 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # GGT DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 405 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD Szasz Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 2801 10 02 81 May 2007/2
*input calibrator value # entered by the user
Item Name # GGT ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 8 MAIN 36 54 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # GGT Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 570 Urine Plasma CSF Dialysis Other Page : 3
845 2500 10 02 81 May 2007/2
Glucose GOD FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # GLUC DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 505 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD GOD Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 2500 10 02 81 May 2007/2
*input calibrator value # entered by the user
Item Name # GLUC ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 46 47 LOW 0.000 REAGENT1 VOL 250 µl SUB 9 10 HIGH 3.000 REAGENT2 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # GLUC Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 400 Urine Plasma CSF Dialysis Other Page : 3
845 2511 10 02 81 September 2007/3
Glucose Hexokinase FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # GLUC DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 380 LOW HIGH LOW HIGH Serum # # # # METHOD Hexokinase Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 2511 10 02 81 September 2007/3
*input calibrator value # entered by the user
Item Name # GLUC ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 240 µl SUB 30 31 HIGH 3.000 REAGENT2 60 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.802 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # GLUC Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 500.0 Urine Plasma CSF Dialysis Other Page : 3
845 3329 10 02 81 January 2010/5
oneHbA1c FS Prestige 24i 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. The stability of the reagent on board the analyser is 8 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # HbA1c DATA INFORMATION CALIBRATION UNITS # TYPE Spline DECIMALS 2 STANDARD #1 * #4 * #2 * #5 ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 660 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD IT Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 3329 10 02 81 January 2010/5
*input calibrator value # entered by the user
Item Name # HbA1c ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 5 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 100 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # HbA1c Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum # Urine Plasma CSF Dialysis Other Page : 3
845 352110 02 81 July 2007/2
HDL-C Immuno FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # HDL DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 600 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD Select Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 352110 02 81 July 2007/2
*input calibrator value # entered by the user
Item Name # HDL ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 240 µl SUB 29 31 HIGH 3.000 REAGENT2 60 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.80198 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # HDL Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1 180 Urine Plasma CSF Dialysis Other Page : 3
845 7202 10 02 81 August 2007/3
Immunoglobulin A FS Prestige 24i 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. 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.
Attention: Calibrators, Controls and Samples must be pre-diluted 1+1 with 0.9% NaCl **This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # IgA DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Logit 2 DECIMALS 0 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 570 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD IT Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7202 10 02 81 August 2007/3
*input calibrator value # entered by the user
Item Name # IgA ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 46 48 LOW 0.000 REAGENT1 VOL 300 µl SUB 30 31 HIGH 3.000 REAGENT2 60 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8347 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # IgA Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 900 Urine Plasma CSF Dialysis Other Page : 3
845 7239 10 02 81
August 2007/3
Immunoglobulin E FS Prestige 24i 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. 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.
Attention: Calibrators, Controls and Samples must be pre-diluted 1+1 with 0.9% NaCl **This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # IgE DATA INFORMATION CALIBRATION UNITS IU/ml TYPE Spline DECIMALS 1 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 570 MALE FEMALE Main W.Length 2 800 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7239 10 02 81
August 2007/3
*input calibrator value # entered by the user
Item Name # IgE ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 5 MAIN 46 48 LOW 0.000 REAGENT1 VOL 200 µl SUB 34 35 HIGH 3.000 REAGENT2 100 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1.000 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # IgE Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1000 Urine Plasma CSF Dialysis Other Page : 3
845 7239 10 02 81
August 2007/3
845 7212 10 02 81 August 2007/2
Immunoglobulin G FS Prestige 24i 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. 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.
Attention: Calibrators, Controls and Samples must be pre-diluted 1+1 with 0.9% NaCl
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # IgG DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Logit 2 DECIMALS 0 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 570 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD IT Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7212 10 02 81 August 2007/2
*input calibrator value # entered by the user
Item Name # IgG ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 46 48 LOW 0.000 REAGENT1 VOL 325 µl SUB 30 31 HIGH 3.000 REAGENT2 65 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8346 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # IgG Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 3500 Urine Plasma CSF Dialysis Other Page : 3
845 7222 10 02 81 August 2007/3
Immunoglobulin M FS Prestige 24i 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. 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.
Attention: Calibrators, Controls and Samples must be pre-diluted 1+1 with 0.9% NaCl **This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # IgM DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Logit 2 DECIMALS 0 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 405 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD IT Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7222 10 02 81 August 2007/3
*input calibrator value # entered by the user
Item Name # IgM ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 46 48 LOW 0.000 REAGENT1 VOL 300 µl SUB 25 26 HIGH 3.000 REAGENT2 60 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.83471 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # IgM Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 800 Urine Plasma CSF Dialysis Other Page : 3
845 1911 10 02 81 July 2007/3
Iron FS Ferene Prestige 24i 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. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # IRON DATA INFORMATION CALIBRATION UNITS µg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 600 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD Ferene Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1911 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # IRON ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 13 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8099 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # IRON Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1000 Urine Plasma CSF Dialysis Other Page : 3
June 2006/3
PRESTIGE 24i Chemistry parameters
Item Name LACTATE
Units [mg/dl] Decimals [1]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [END] MainW. Length1 [340] Subw. Length2 [800] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Double] Sample Volume [4 µl] Reagent 1 Volume [240 µl] Reagent 2 Volume [60 µl]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [52] – [54] Sub [30] – [31] Absorbance Limit [-0.100] – [2.000] Linear Check [40%] Endpoint Limit [2.000]
Factor: Blank Correction [0.803]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [#] High-SW [Off] Serum [#] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
LACTATE FS Order information Cat. No. Kit size 1 4001 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml
1 4001 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml
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. 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
**This application proposal is for guidelines only. To
avoid misinterpretation measured results have to be validated and assessed with caution.
June 2006/3
January 2005/2
PRESTIGE 24i Chemistry parameters
Item Name LDH
Units [U/l] Decimals [0]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [RATE] MainW. Length1 [340] Subw. Length2 [450] Method [DGKC]
N-Range Male and Female [#] – [#]
Reagent Kind [Double] Sample Volume [5 µl] Reagent 1 Volume [200 µl] Reagent 2 Volume [50 µl]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [35] – [54] Sub [ ] – [ ] Absorbance Limit [-3.000] – [3.000] Linear Check [90%] Endpoint Limit [0.000]
Factor: Blank Correction [1.000]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [0] High-SW [Off] Serum [Off] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
LDH FS DGKC Order information Cat. No. Kit size 10 420 021 R1 5 x 20 ml + R2 1 x 25 ml
10 420 022 R1 5 x 80 ml + R2 1 x 100 ml
10 420 023 R1 1 x 800 ml + R2 1 x 200 ml
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. 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
**This application proposal is for guidelines only. To
avoid misinterpretation measured results have to be validated and assessed with caution.
January 2005/2
845 4211 10 02 81 July 2007/3
LDH FS IFCC Prestige 24i 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. The stability of the reagent on board the analyser is 10 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # LDH DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 0 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 - LOW HIGH LOW HIGH Serum # # # # METHOD IFCC Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 4211 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # LDH ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 4 MAIN 35 52 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT - Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # LDH Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1500 Urine Plasma CSF Dialysis Other Page : 3
845 4121 10 02 81 May 2007/2
LDL-C Select FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # LDL DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 600 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD Select Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 4121 10 02 81 May 2007/2
*input calibrator value # entered by the user
Item Name # LDL ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.80237 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # LDL Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 400 Urine Plasma CSF Dialysis Other Page : 3
845 4321 10 02 81 July 2007/3
Lipase DC FS Prestige 24i 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. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # LIP DATA INFORMATION CALIBRATION UNITS U/l TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 570 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 4321 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # LIP ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 5 MAIN 37 43 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # LIP Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 300 Urine Plasma CSF Dialysis Other Page : 3
845 7139 10 02 81
May 2008/3
Lp(a) 21 FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # Lp(a) DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Spline DECIMALS 1 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 700 MALE FEMALE Main W.Length 2 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7139 10 02 81
May 2008/3
*input calibrator value # entered by the user
Item Name # Lp(a) ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 5 MAIN 53 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 35 36 HIGH 3.000 REAGENT2 100 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1.000 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # Lp(a) Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 3 130 Urine Plasma CSF Dialysis Other Page : 3
January 2005/2
PRESTIGE 24i Chemistry parameters
Item Name MG
Units [mg/dl] Decimals [1]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [END] MainW. Length1 [546] Subw. Length2 [700] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Single] Sample Volume [3 µl] Reagent 1 Volume [250 µl] Reagent 2 Volume [ ]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [31] – [32] Sub [9] – [10 ] Absorbance Limit [-3.000] – [3.000] Linear Check [40%] Endpoint Limit [2.000]
Factor: Blank Correction [1.000]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [Off] High-SW [Off] Serum [Off] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
MAGNESIUM XL FS Order information Cat. No. Kit size 1 4610 99 10 021 R 5 x 25 ml + 1 x 3 ml Std
1 4610 99 10 026 R 6 x 100 ml
1 4610 99 10 023 R 1 x 1000 ml
1 4610 99 10 030 6 x 3 ml Standard
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. 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
**This application proposal is for guidelines only. To
avoid misinterpretation measured results have to be validated and assessed with caution.
845 5211 10 02 81 January 2009/3
Phosphate FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # P DATA INFORMATION CALIBRATION UNITS mmol/l TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 660 LOW HIGH LOW HIGH Serum # # # # METHOD DIASYS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 5211 10 02 81 January 2009/3
*input calibrator value # entered by the user
Item Name # P ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 52 54 LOW 0.000 REAGENT1 VOL 240 µl SUB 30 31 HIGH 3.000 REAGENT2 60 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.802 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # P Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 9.69 Urine Plasma CSF Dialysis Other Page : 3
845 7022 10 02 81 July 2007/3
Rheumatoid Factor FS Prestige 24i 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. The stability of the reagent on board the analyser is 3 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # RF DATA INFORMATION CALIBRATION UNITS IU/ml TYPE Logit 2 DECIMALS 1 STANDARD #1 * #4 * #2 * #5 * ANALYSIS #3 * #6 TYPE END NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD IT Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 7022 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # RF ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 12 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 40 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.80916 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # RF Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 500 Urine Plasma CSF Dialysis Other Page : 3
March 2006/3
PRESTIGE 24i Chemistry parameters
Item Name TPU
Units [mg/l] Decimals [0]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [END] MainW. Length1 [600] Subw. Length2 [700] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Single] Sample Volume [5 µl] Reagent 1 Volume [250 µl] Reagent 2 Volume [ ]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [46] – [47] Sub [9] – [10 ] Absorbance Limit [-0.100] – [2.000] Linear Check [40%] Endpoint Limit [2.000]
Factor: Blank Correction [1.000]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [0] High-SW [Off] Serum [300] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
TOTAL PROTEIN UC FS Order information Cat. No. Kit size
1 0210 99 10 021 R 5 x 25 ml + 1 x 3 ml Std
1 0210 99 10 026 R 6 x 100 ml
1 0210 99 10 730 R 6 x 20 ml
1 0210 99 10 030 6 x 3 ml Standard
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. 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
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 2311 10 02 81 August 2007/2
Total Protein FS Labmax 240 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. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # TPRO DATA INFORMATION CALIBRATION UNITS g/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 546 MALE FEMALE Main W.Length 2 LOW HIGH LOW HIGH Serum # # # # METHOD Biuret Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 2311 10 02 81 August 2007/2
*input calibrator value # entered by the user
Item Name # TPRO ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 6 MAIN 52 54 LOW 0.000 REAGENT1 VOL 240 µl SUB 30 31 HIGH 3.000 REAGENT2 60 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.8039 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # TPRO Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 15.0 Urine Plasma CSF Dialysis Other Page : 3
June 2006/3
PRESTIGE 24i Chemistry parameters
Item Name TRF
Units [mg/dl] Decimals [1]
Calibration Type [Spline] 1 [0.0 ] 2 [Cal 1 ] 3 [Cal 2 ] 4 [Cal 3 ] 5 [Cal 4 ] 6 [Cal 5 ]
Method Type [END] MainW. Length1 [570] Subw. Length2 [0 ] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Double] Sample Volume [3 µl] Reagent 1 Volume [300 µl] Reagent 2 Volume [60 µl]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [52] – [54] Sub [30] – [31] Absorbance Limit [-0.100] – [2.000] Linear Check [40%] Endpoint Limit [ ]
Factor: Blank Correction [0.835]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [#] High-SW [Off] Serum [#] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
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. 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
**This application proposal is for guidelines only. To
avoid misinterpretation measured results have to be validated and assessed with caution.
845 5710 10 02 81 May 2007/2
Triglycerides FS Prestige 24i 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. 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.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # TRIG DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 505 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD GPO Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 5710 10 02 81 May 2007/2
*input calibrator value # entered by the user
Item Name # TRIG ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 46 47 LOW 0.000 REAGENT1 VOL 200 µl SUB 9 10 HIGH 2.000 REAGENT2 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # TRIG Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 1000 Urine Plasma CSF Dialysis Other Page : 3
845 1921 10 02 81 July 2007/3
UIBC FS Prestige 24i 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. The stability of the reagent on board the analyser is 6 days provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # UIBC DATA INFORMATION CALIBRATION UNITS µg/dl TYPE Linear DECIMALS 0 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 600 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD Ferene Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 1921 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # UIBC ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 15 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.81132 LINEAR CHECK(%) 0 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # UIBC Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 6 750 Urine Plasma CSF Dialysis Other Page : 3
845 3101 10 02 81 March 2009/4
Urea FS Prestige 24i 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. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # UREA DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 1 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE RATE NORMAL RANGE Main W.Length 1 340 MALE FEMALE Main W.Length 2 380 LOW HIGH LOW HIGH Serum # # # # METHOD UV Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 3101 10 02 81 March 2009/4
*input calibrator value # entered by the user
Item Name # UREA ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 3 MAIN 35 42 LOW 0.000 REAGENT1 VOL 200 µl SUB HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 1 LINEAR CHECK(%) 90 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # UREA Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 2 300 Urine Plasma CSF Dialysis Other Page : 3
June 2006/3
PRESTIGE 24i Chemistry parameters
Item Name UA
Units [mg/dl] Decimals [1]
Calibration Type [Linear] 1 [* ] 2 [* ] 3 [ ] 4 [ ] 5 [ ] 6 [ ]
Method Type [END] MainW. Length1 [505] Subw. Length2 [700] Method [ ]
N-Range Male and Female [#] – [#]
Reagent Kind [Double] Sample Volume [4 µl] Reagent 1 Volume [200 µl] Reagent 2 Volume [50 µl]
Co-ordinate Y = [1.000] X + [0.000] Monitor Zero level point [1] Monitor Span [3.000] Third mix [Off] Water Blank [On]
Read Main (Start-End) [52] – [54] Sub [30] – [31] Absorbance Limit [-0.100] – [2.000] Linear Check [40%] Endpoint Limit [2.000]
Factor: Blank Correction [0.803]
Prozone Read 1 [ ] – [ ] 2 [ ] – [ ] 3 [ ] – [ ] Limit 2 [ ] – [ ] 3 [ ] – [ ]
Auto Rerun SW [Off] Range (Result ) Low-SW [Off] Serum [#] High-SW [Off] Serum [#] Absorbance Low-SW [Off] High-SW [Off] Prozone-SW [Off]
#) Data entry by the user *) Input Standard or Calibrator value
URIC ACID FS TBHBA Order information Cat. No. Kit size 10 302 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std
1 3021 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml
10 302 023 R1 1 x 800 ml + R2 1 x 200 ml
10 302 030 6 x 3 ml Standard
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. 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
**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.
845 3001 10 02 81 July 2007/3
Uric Acid (Toos) FS Prestige 24i 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. The stability of the reagent on board the analyser is 6 weeks provided that contamination and evaporation are avoided.
3. Manufactured by: DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany.
**This application was set up and evaluated at DiaSys. It is based on the standard equipment at that time and does not apply to any equipment modifications undertaken by the manufacturer or by other persons.
*input calibrator value # entered by the user
Item Name # UA DATA INFORMATION CALIBRATION UNITS mg/dl TYPE Linear DECIMALS 2 STANDARD #1 * #4 #2 #5 ANALYSIS #3 #6 TYPE END NORMAL RANGE Main W.Length 1 546 MALE FEMALE Main W.Length 2 700 LOW HIGH LOW HIGH Serum # # # # METHOD TOOS Urine Plasma CSF Dialysis CORR. Other SLOPE INTER Y = 1 X + 0 Page : 1
845 3001 10 02 81 July 2007/3
*input calibrator value # entered by the user
Item Name # UA ASPIRATION DATA PROCESS KIND Single Double READ ABSORBANCE LIMIT VOLUME START END SAMPLE 5 MAIN 52 54 LOW 0.000 REAGENT1 VOL 200 µl SUB 30 31 HIGH 3.000 REAGENT2 50 FACTOR ENDPOINT LIMIT 2.000 Third Mix. OFF ON Blk correction 0.80392 LINEAR CHECK(%) 80 R1 Blank Water Blk R1 Blank1 Dilution MONITOR Diluent 99:Dil1 100:Dil2 0 LEVEL POINT 1 SPAN 3 PROZONE CHECK START END LIMIT(%) FIRST SECOND Low High THIRD Low High Page : 2
Item Name # UA Auto Rerun SW Auto Rerun Condition (Absorbance On Off Absorbance Range Lower On Off Higher On Off Auto Rerun Range (Result) On Off On Off Prozone Range On Off Lower Higher Serum 0.3 20.0 Urine Plasma CSF Dialysis Other Page : 3