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Features, Advantages, and Bene�ts
DS-H7546-01 06/18
Features
Patented antibody with high specificity for HbA1c
Fully Automated
Direct measurement of HbA1c
Does not require a standalone system
NGSP Certification & Traceable to IFCC Standard
Advantages
Minimizes cross-reactivity from hemoglobin variant molecules
No offline sample pretreatment
Does not require additional channel for determination of
total hemoglobin
Eliminates the need for HbA1c specific analyzers
Standardized tests results to test methods used in clinical studies
Benefits
More precise results » no interference from hemoglobin variants / adducts; Carbamylated Hb, Acetylated Hb, HbA2, HbS, HbC, HbE and HbD
Streamline testing process with more accurate results and less
hands-on activities
Saves space on analyzer and cost of running additional test
Save laboratory space and money by the consolidation of clinical
laboratory equipment
Increase patient confidence by a NGSP certified test
Ordering Information
Product Number Analyzer Speci�c Description
H7546-40 Open Channel R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL
REAGENTS
H7541-CALCALIBRATORS
H7546-120 Open Channel R1: 1 x 90 mL, R2: 1 x 30 mL
OH546-40 Beckman AU R1: 2 x 15 mL, R2: 1 x 10 mL
HBA-480 BS-480 R1: 2 x 60 mL, R2: 2 x 20 mL
HBA-600 BS-200 R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL
12-H7546-40 BS-200(International)
R1: 1 x 30 mL, R2: 1 x 10 mLLyse: 1 x 125 mL
H7541-CTLCONTROLS
Lyophilized
Lyophilized
1 vial each of 4 levels
2 vials each of 2 levels
Instrument Applications
• Abbot Aeroset• Alycon• ATAC 8000 • Beckman/Olympus AU400, AU640, AU2700, AU5400, CX, DxC, LX • Bayer Advia 1650, 1800, 2400• Biolis 24i• Biotecnica BT2000/3000• Chemwell• Cobas 6000, c501, Mira, Mira Plus• Envoy 500• Express• Dimension
• Hitachi - 704, 717, 747, 902, 911, 912, 914, 917• Konelab 20, 30, 60• Mindray - BS-200, BS-300, BS-400, BS-480, BA-800M • Pentra 400• Pointe 360• Prestige 24i• RA - 500, 1000• Randox Daytona• Selectra SE• Sirrus• Spectrum• Targa • Vitros 5
Mindray Analyzer Series Sheet
Today’s lab environment is highly complex. On one hand there is increasing volume and requirements driven by an aging population, new diseases and changing models for specimen coverage. On the other hand, the laboratory is expected to reduce costs for operation. Now that healthcare professionals will be rewarded for helping patients improve their health and reduce the incidence of chronic diseases, the demand for general chemistry tests will increase.
Product
The Pointe brand is constantly expanding to provide laboratories with an increased choice of high quality diagnostics tests. Building on over 30 years of experience and expertise in the field of diagnostics has enabled the brand to offer high quality reagents with exceptional performance. There are several pack size varieties available providing laboratories with complete flexibility and versatility. With applications available for most instruments, switching to Pointe brand reagents is simple. Pointe brand developed theoretical and validated applications for the Mindray analyzer series, shown in Figure 1.
Regulatory and Certification
• 510(k) Cleared• CE Marked• ISO 13485 Certified• cGMP Compliant• CLIA Classification
Market: General Chemistry Testing
Pointe brand Instrument Specific Reagents:Superior reagents manufactured in the U.S and packaged for use on the Mindray analyzers
Figure 1:
Mindray Analyzer Series
800.445.9853(International) +1.734.487.8300 www.medtestdx.com
Mindray BS-200
Mindray BS-480
Mindray BA-800M
Made in USA
CertifiedPerformanceGuarantee
800.445.9853www.medtestdx.com
MINDRAY BS-200 MINDRAY BS-480 MINDRAY BA-800M
Applications AvailableModerately Complex
AlbuminAlcohol
Alkaline PhosphataseALT
AmmoniaAmylase
ASTBilirubin-DirectBilirubin-Total
BUN (Urea Nitrogen)Calcium
Carbon DioxideCholesterol
CK-MBCreatinine
Creatine KinaseCRP
G6PDGlucose Hexokinase
y-Glutamyl TransferaseautoHDL™ Cholesterol
Hemoglobin A1cHomocysteine
β-HydroxybutyrateIron-Total
LactateLactate Dehydrogenase
autoLDL™ CholesterolLipoprotein (a)
LipaseMagnesium
MicroalbuminMicroproteinPhosphorousProtein-TotalTIBC - Direct
Triglycerides - LiquidUric Acid
12-A7502-160*A750412-A7516-100*12-A7526-100*A755312-A7564-120*12-A7561-100*12-HB936-156*12-HB979-192*12-B7552-150*12-C7529-120*12-C7502-160*12-C7510-160*C756212-C7539-98*12-C7522-100*12-C7568-40G758312-G7517-16012-G7571-100*12-H7545-162*12-H7546-40*H7575H758712-HI904-144*L759612-L7572-100*12-L7574-162*L759712-L7503-4012-HM729-160*M7562*P758212-P7516-160*12-T7528-120*I751712-T7532-160*12-U7581-120*
14-A7502-480*
14-A7516-225*14-A7526-375*
14-A7564-120*14-A7561-375*14-HB936-200*14-HB979-365*14-B7552-600*14-C7529-360*14-C7502-160*14-C7510-480*
14-C7539-432*14-C7522-22014-C7568-480
14-G7517-480*14-G7571-200*14-H7545-300*14-H7546-160*14-H7575-144H758714-HI904-350*14-L7596-380*14-L7572-200*14-L7574-320*14-L7597-216L750314-HM929-240*
14-P7516-174*14-T7528-480*14-I7517-384*14-T7532-480*14-U7581-160*
16-A7502-396*
16-A7516-252*16-A7526-420*
16-HA965-223*16-A7561-420*16-HB936-186*16-HB979-395*16-B7552-591*16-HC902-480*16-C7502-180*16-C7510-520*
16-C7539-487*16-C7522-225
16-G7517-528*16-HG959-236*16-H7545-320*16-H7546-200*
16-HI904-398*16-L7596-40016-HL956-236*16-L7574-400*
16-HM929-250*
16-HP916-192*16-HT928-708*16-I7517-400*16-T7532-520*16-HU982-308*
REAGENTS
FL-M3111-05.3
*
16-C7568-480
L7597
Made in USA
CertifiedPerformanceGuarantee
“MedTest Dx certifies that all of our products are manufactured according to specified parameters. Any product not meeting specifications through their listed expiration date will be remedied immediately without charge..”