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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 03610230005071 1220001645 KHS Enzymatic, Carbon-Dioxide 2 ABX PENTRA CO2 RTU
2 03610230004692 1210906013 GGK Products, Red-Cell Lysing Products 1 ABX LYSEBIO (0.4L)
3 03610230009314 1300076291 JIT Calibrator, Secondary 2 Yumizen C1200 LDL Cal
4 03610230009284 1300071247 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Yumizen C1200 Level 1 CRPhs Control
5 03610230009055 1300054414 1300054414 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 ABX Pentra N MultiControl
6 03610230008621 1300047912 JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) 1 Yumizen C1200 Urinary Proteins
7 03610230008232 1300032565 DCF Albumin, Antigen, Antiserum, Control 2 ABX Pentra Micro ALB 2 Cal
8 03610230007938 1300023951 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Yumizen C1200 L1 Cystatin C Control
9 03610230007709 1300023938 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Yumizen C1200 N Multi Control
10 03610230007624 1300023921 JIT Calibrator, Secondary 2 Yumizen C1200 CO2 Cal
11 03610230007396 1300023887 JZJ Prealbumin, Antigen, Antiserum, Control 1 Yumizen C1200 Prealbumin
12 03610230007198 1300023867 CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 Yumizen C1200 Triglycerides
13 03610230007174 1300023865 CEK Biuret (Colorimetric), Total Protein 2 Yumizen C1200 Total Protein
14 03610230007112 1300023859 JGJ Photometric Method, Magnesium 1 Yumizen C1200 Magnesium
15 03610230006856 1300023832 CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1 Yumizen C1200 AST
16 03610230006771 1300017438 JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 ABX PENTRA PRECITEST SOLUTION
17 03610230006702 1220001765 JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use SAMPLE CUP - BLUE
18 03610230006191 1280070107 ABX MICROS 60 (O.S.B.) GKZ Counter, Differential Cell 2 ABX MICROS 60 OS
19 03610230006160 1280070105, 1280070106 ABX MICROS 60 (O.S.B.) GKZ Counter, Differential Cell 2 ABX MICROS 60 OS
20 03610230005866 3014029451 JJP Electrode, Ion Selective (Non-Specified) 1 ABX PENTRA REFERENCE-E
21 03610230005736 1220001933 CGX Alkaline Picrate, Colorimetry, Creatinine 2 ABX PENTRA CREATININE 120 CP
22 03610230005583 1220001891 JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use CUVETTE SEGMENTS RACK
23 03610230005460 1220001730 GGK Products, Red-Cell Lysing Products 1 ABX PENTRA HBA1C WB HEMOLYSIS REAGENT
24 03610230005200 1220001667 CFR Hexokinase, Glucose 2 ABX PENTRA GLUCOSE HK CP
25 03610230005170 1220001662 GIF Diluent, Blood Cell 1 ABX PENTRA SAMPLE DILUENT CP
26 03610230005101 1220001648 JIT Calibrator, Secondary 2 ABX PENTRA CO2 CAL
27 03610230005033 1220001640 CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides 1 ABX PENTRA TRIGLYCERIDES CP
28 03610230005026 1220001639 CIG Diazo Colorimetry, Bilirubin 2 ABX PENTRA BILIRUBIN, TOTAL CP
29 03610230004944 1220001631 CHI Lipase-Esterase, Enzymatic, Photometric, Lipase 1 ABX PENTRA LIPASE CP
30 03610230004906 1220001627 CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt 1 ABX PENTRA ALT CP
31 03610230007297 1300023877 Yumizen C1200 CRP ( conventional application)Yumizen C1200 CRP (hs application ) DCK C-Reactive Protein, Antigen, Antiserum, And Control 2 Yumizen C1200 CRP
32 03610230006115 1280200072 GKZ Counter, Differential Cell 2 ABX MICROS ES 60
33 03610230005088 1220001646 JGJ Photometric Method, Magnesium 1 ABX PENTRA MAGNESIUM RTU
34 03610230007877 1300023946 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Yumizen C Urine Level 1 Control
35 03610230007891 1300023948 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Yumizen C1200 U/CSF L1 Micro Alb Control
36 03610230007860 1300023945 JJY Multi-Analyte Controls, All Kinds (Assayed) 1 Yumizen C1200 Level 2 Protein Control
37 03610230007235 1300023871 DCF Albumin, Antigen, Antiserum, Control 2 Yumizen C1200 Albumin U/CSF
38 03610230007211 1300023869 CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen 2 Yumizen C1200 Urea
39 03610230006993 1300023846 JQB Kinetic Method, Gamma-Glutamyl Transpeptidase 1 Yumizen C1200 GGT
40 03610230006917 1300023838 CHH Enzymatic Esterase--Oxidase, Cholesterol 1 Yumizen C1200 Cholesterol
41 03610230006863 1300023833 KHS Enzymatic, Carbon-Dioxide 2 Yumizen C1200 CO2
42 03610230006832 1300023830 CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes 2 Yumizen C1200 ALP
43 03610230006672 1280090002 JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 PENTRA C200 ISE
44 03610230006498 1280160014, 1280160016 KPA Slide Stainer, Automated 1 ABX SPS EVOLUTION
45 03610230006481 1280160018, 1280160020 KPA Slide Stainer, Automated 1 ABX SPS EVOLUTION
46 03610230006290 1280100006, 1280100007, 1280100008, 1280100010 100 or 110V, ready for SPS GKZ Counter, Differential Cell 2 ABX PENTRA DF 120
47 03610230005859 3014029450 CEM Electrode, Ion Specific, Potassium 2 ABX PENTRA POTASSIUM-E
48 03610230005767 1220001965 DCF Albumin, Antigen, Antiserum, Control 2 ABX PENTRA MICRO ALBUMIN CP
49 03610230005507 1220001758 JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 ABX PENTRA QUALITEST SOLUTION
50 03610230005125 1220001652 JIX Calibrator, Multi-Analyte Mixture 2 ABX PENTRA MULTICAL
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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10 03610230005392 1220001702 ABX PENTRA HBA1C WB HORIBA ABX SAS
11 03607360025154 2515 2515 Device intended for measurement of HbA1c in whole blood using capillary electrophoresis CAPI 3 Hb A1c SEBIA
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16 00857969006242 SA1044 SA1044 Hemoglobin A1c Reagent ACE ALFA WASSERMANN, INC.
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22 00850006113033 CURO A1c Curo A1c Test Cartridge CURO A1c KPI HEALTHCARE, INC.
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25 00847817025679 290-1010 2901010 D-100 HbA1c Elution Buffer A D-100 BIO-RAD LABORATORIES, INC.
26 00847817020155 290-1006 2901006 D-100 HbA1c Calibrator Pack D-100 BIO-RAD LABORATORIES, INC.
27 00847817016035 290-1012 2901012 D-100 Wash Solution D-100 BIO-RAD LABORATORIES, INC.
28 00847817016028 290-1011 2901011 D-100 HbA1c Elution Buffer B D-100 BIO-RAD LABORATORIES, INC.
29 00847817016004 290-1009 2901009 D-100 Sample Diluent D-100 BIO-RAD LABORATORIES, INC.
30 00847817015991 290-1008 2901008 D-100 Cleaning Tube D-100 BIO-RAD LABORATORIES, INC.
31 00847817015953 290-1004 2901004 D-100 HbA1c Analytical Cartridge/Calibrator Pack D-100 BIO-RAD LABORATORIES, INC.
32 00847817014901 270-2726 2702726 VARIANT II TURBO Link Hemoglobin A1c Program Guard Cartridge VARIANT II TURBO Link BIO-RAD LABORATORIES, INC.
33 00847817014895 270-2725 2702725 VARIANT II TURBO Link Hemoglobin A1c Program Analytical Cartridge VARIANT II TURBO Link BIO-RAD LABORATORIES, INC.
34 00847817014888 270-2724 2702724 VARIANT II TURBO Link Hemoglobin A1c Program Cartridge Set VARIANT II TURBO Link BIO-RAD LABORATORIES, INC.
35 00847817014871 270-2722 2702722 VARIANT II TURBO Link Hemoglobin A1c Program Calibrator/Diluent Set VARIANT II TURBO Link BIO-RAD LABORATORIES, INC.
36 00847817014833 270-2718 2702718 VARIANT II TURBO Link Hemoglobin A1c Program Elution Buffer B VARIANT II TURBO Link BIO-RAD LABORATORIES, INC.
37 00847817014468 270-2464 2702464 VARIANT II TURBO HbA1c Kit - 2.0 Prefilter VARIANT II TURBO BIO-RAD LABORATORIES, INC.
38 00847817014444 270-2462 2702462 VARIANT II TURBO HbA1c Kit - 2.0 Analytical Cartridge VARIANT II TURBO BIO-RAD LABORATORIES, INC.
39 00847817014406 270-2458 2702458 VARIANT II TURBO HbA1c Kit - 2.0 Calibrator/Diluent Set VARIANT II TURBO BIO-RAD LABORATORIES, INC.
40 00847817014390 270-2457 2702457 VARIANT II TURBO HbA1c Kit - 2.0 Elution Buffer B VARIANT II TURBO BIO-RAD LABORATORIES, INC.
41 00847817014383 270-2456 2702456 VARIANT II TURBO HbA1c Kit - 2.0 Elution Buffer A VARIANT II TURBO BIO-RAD LABORATORIES, INC.
42 00847817014369 270-2455 2702455 VARIANT II TURBO HbA1c Kit - 2.0 VARIANT II TURBO BIO-RAD LABORATORIES, INC.
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44 00847817014154 270-2422 2702422 VARIANT II TURBO Hemoglobin A1c Program Calibrator/Diluent Set VARIANT II TURBO BIO-RAD LABORATORIES, INC.
45 00847817014093 270-2412 2702412 VARIANT II TURBO Hemoglobin A1c Program Guard Cartridge VARIANT II TURBO BIO-RAD LABORATORIES, INC.
46 00847817014079 270-2411 2702411 VARIANT II TURBO Hemoglobin A1c Program Analytical Cartridge VARIANT II TURBO BIO-RAD LABORATORIES, INC.
47 00847817013966 270-2404 270-2404 VARIANT II TURBO Hemoglobin A1c Program Calibrator/Diluent Set VARIANT II TURBO BIO-RAD LABORATORIES, INC.
48 00847817013928 270-2402 270-2402 VARIANT II TURBO Hemoglobin A1c Program Elution Buffer B VARIANT II TURBO BIO-RAD LABORATORIES, INC.
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