Other products from "KAMIYA BIOMEDICAL COMPANY, LLC"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00816426021679 K180C-2M K180C-2M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP). JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 K-ASSAY® hsCRP Control
2 00816426021464 KAI-231C KAI-231C For the calibration of the K-ASSAY® RF (Ver.2) assay JIS Calibrator, Primary 2 K-ASSAY® RF Calibrator (Ver.2)
3 00816426021303 KAI-282C KAI-282C For the calibration of the K-ASSAY® Beta-2 Microglobulin assay. JZG System, Test, Beta-2-Microglobulin Immunological 2 K-ASSAY® Beta-2 Microglobulin Urine Calibrator
4 00816426021297 KAI-281C KAI-281C For the calibration of the K-ASSAY® Beta-2 Microglobulin assay. JZG System, Test, Beta-2-Microglobulin Immunological 2 K-ASSAY® Beta-2 Microglobulin Serum / Plasma Calibrator
5 00816426020528 KAI-197 KAI-197 For the quantitative determination of human hemoglobin A1c (HbA1c) in whole blood. LCP Assay, Glycosylated Hemoglobin 2 K-ASSAY® Hemoglobin A1c Reagent (L)
6 00816426020344 KAI-082 KAI-082 For the quantitative determination of human C-reactive protein (CRP) in serum an For the quantitative determination of human C-reactive protein (CRP) in serum and plasma by immunoturbidimetric assay. DCK C-Reactive Protein, Antigen, Antiserum, And Control 2 K-ASSAY® CRP (3) Reagent
7 00816426020191 KAI-031 KAI-031 For the quantitative determination of human rheumatoid factor (RF) in serum by i For the quantitative determination of human rheumatoid factor (RF) in serum by immunoturbidimetric assay. DHR System, Test, Rheumatoid Factor 2 K-ASSAY® RF Reagent
8 00816426020139 KAI-019 KAI-019 For the quantitative determination of human albumin in urine by immunoturbidimet For the quantitative determination of human albumin in urine by immunoturbidimetric assay. DCF Albumin, Antigen, Antiserum, Control 2 K-ASSAY® Microalbumin Reagent
9 00816426020108 KAI-014 KAI-014 For the quantitative determination of human IgG in serum by immunoturbidimetric assay. DEW Igg, Antigen, Antiserum, Control 2 K-ASSAY® IgG Reagent
10 00816426021402 KAI-301 KAI-301 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. JMO Ferrozine (Colorimetric) Iron Binding Capacity 1 K-ASSAY® UIBC Reagent (L)
11 00816426021082 KAI-136C KAI-136C For the calibration of the K-ASSAY® Fibrinogen assay. GIS Test, Fibrinogen 2 K-ASSAY® Fibrinogen Calibrator
12 00816426020658 KAI-089C KAI-089C For the calibration of the K-ASSAY® Fibrinogen assay. GIS Test, Fibrinogen 2 K-ASSAY® Fibrinogen Calibrator
13 00816426020801 K37C-SAM K37C-SAM For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for microalbumin. JJW Urinalysis Controls (Assayed And Unassayed) 1 K-ASSAY® Microalbumin Urine Control
14 00816426020795 K37C-4M K37C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for microalbumin. JJW Urinalysis Controls (Assayed And Unassayed) 1 K-ASSAY® Microalbumin Urine Control
15 00816426020597 KAI-048C KAI-048C For the calibration of the K-ASSAY® Fructosamine assay. LCP Assay, Glycosylated Hemoglobin 2 K-ASSAY® Fructosamine Calibrator
16 00816426020313 KAI-073 KAI-073 For the quantitative determination of human cystatin C in serum, EDTA plasma, or For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. NDY Test, Cystatin C 2 K-ASSAY® Cystatin C Reagent
17 00816426020252 KAI-046 KAI-046 For the quantitative determination of human ferritin in serum and plasma by immu For the quantitative determination of human ferritin in serum and plasma by immunoturbidimetric assay. DBF Ferritin, Antigen, Antiserum, Control 2 K-ASSAY® Ferritin Reagent (L)
18 00816426020238 KAI-043 KAI-043 For the quantitative determination of fructosamine in serum. LCP Assay, Glycosylated Hemoglobin 2 K-ASSAY® Fructosamine Reagent + Calibrator
19 00816426020115 KAI-015 KAI-015 For the quantitative determination of human IgM in serum by immunoturbidimetric assay. CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) 2 K-ASSAY® IgM Reagent
20 00816426020078 KAI-009 KAI-009 For the quantitative determination of human 3rd complement component (Complement For the quantitative determination of human 3rd complement component (Complement C3) in serum by immunoturbidimetric assay. CZW Complement C3, Antigen, Antiserum, Control 2 K-ASSAY® Complement C3 Reagent
21 00816426021044 K59C-L3 K59C-L3 For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 K-ASSAY® Ferritin / IgE / Insulin Control, L3
22 00816426020887 K80C-4M K80C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for C-reactive protein (CRP). DCK C-Reactive Protein, Antigen, Antiserum, And Control 2 K-ASSAY® hs-CRP Control
23 00816426020856 K55C-4M K55C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 K-ASSAY® ASO/RF/CRP Control
24 00816426020849 K55C-2M K55C-2M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 K-ASSAY® ASO/RF/CRP Control
25 00816426020788 K29C-4M K29C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for hemoglobin A1c. LCP Assay, Glycosylated Hemoglobin 2 K-ASSAY® Hemoglobin A1c Control
26 00816426020566 KAI-016C KAI-016C For the calibration of the K-ASSAY® Alpha-1 AG, Alpha-1 AT, Complement C3, Comle For the calibration of the K-ASSAY® Alpha-1 AG, Alpha-1 AT, Complement C3, Comlement C4, Haptoglobin, IgA, IgG, IgM, and Transferrin assays. JIX Calibrator, Multi-Analyte Mixture 2 K-ASSAY® Multi-Analyte Calibrator
27 00816426020412 KAI-072C KAI-072C For the calibration of the K-ASSAY® Insulin assay. CFP Radioimmunoassay, Immunoreactive Insulin 1 K-ASSAY® Insulin Calibrator
28 00816426020337 KAI-078 KAI-078 For the quantitative determination of human streptolysin O (ASO) in serum by imm For the quantitative determination of human streptolysin O (ASO) in serum by immunoturbidimetric assay. GTQ Antistreptolysin - Titer/Streptolysin O Reagent 1 K-ASSAY® ASO (WHO) Reagent
29 00816426020214 KAI-035 KAI-035 For the quantitative determination of human fibrinogen in plasma. GIS Test, Fibrinogen 2 K-ASSAY® Fibrinogen Reagent + Calibrator
30 00816426020177 KAI-024 KAI-024 For the quantitative determination of human apolipoprotein B (Apo B) in serum by For the quantitative determination of human apolipoprotein B (Apo B) in serum by immunoturbidimetric assay. DER Alpha-1-Lipoprotein, Antigen, Antiserum, Control 2 K-ASSAY® Apo B Reagent (L)
31 00816426020092 KAI-013 KAI-013 For the quantitative determination of human IgA in serum by immunoturbidimetric assay. CFF Immunoelectrophoretic, Immunoglobulins, (G, A, M) 2 K-ASSAY® IgA Reagent
32 00816426020009 KAI-001 KAI-001 For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in For the quantitative determination of human alpha-1 anti-trypsin (Alpha-1 AT) in serum by immunoturbidimetric assay. DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control 2 K-ASSAY® Alpha-1 AT Reagent
33 00816426021648 K310C-4M K310C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for Apolipoprotein AI and B. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 K-ASSAY® Apo AI / B Control
34 00816426021419 KAI-302C KAI-302C For the calibration of the K-ASSAY® UIBC assay. JMO Ferrozine (Colorimetric) Iron Binding Capacity 1 K-ASSAY® UIBC Calibrator
35 00816426021341 K284C-4M K284C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 K-ASSAY® Beta-2 Microglobulin Urine Control
36 00816426021334 K284C-2M K284C-2M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 K-ASSAY® Beta-2 Microglobulin Urine Control
37 00816426021273 K92C-4M K92C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer. GGN Plasma, Coagulation Control 2 K-ASSAY® D-Dimer Control
38 00816426021266 K92C-2M K92C-2M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer. GGN Plasma, Coagulation Control 2 K-ASSAY® D-Dimer Control
39 00816426020863 K59C-3M K59C-3M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for the listed constituents. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 K-ASSAY® Ferritin / IgE / Insulin Control
40 00816426020559 KAI-012C KAI-012C For the calibration of the K-ASSAY® CRP assay. DCK C-Reactive Protein, Antigen, Antiserum, And Control 2 K-ASSAY® CRP Calibrator
41 00816426020764 KAI-206C KAI-206C For the calibration of the K-ASSAY® Factor XIII assay. DBT Factor Xiii A, S, Antigen, Antiserum, Control 1 K-ASSAY® Factor XIII Calibrator
42 00816426020719 KAI-106C KAI-106C For the calibration of the K-ASSAY® Factor XIII assay. DBT Factor Xiii A, S, Antigen, Antiserum, Control 1 K-ASSAY® Factor XIII Calibrator
43 00816426020542 KAI-008C KAI-008C For the calibration of the K-ASSAY® Apo AI and Apo B assays. JIX Calibrator, Multi-Analyte Mixture 2 K-ASSAY® Apo AI/B Calibrator
44 00816426020375 KAI-092 KAI-092 For the quantitative determination of human total IgE in serum or plasma by immu For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay. DGC Ige, Antigen, Antiserum, Control 2 K-ASSAY® Total IgE Reagent
45 00816426020368 KAI-090 KAI-090 For the quantitative determination of human D-dimer in plasma or serum by immuno For the quantitative determination of human D-dimer in plasma or serum by immunoturbidimetric assay. GHH Fibrin Split Products 2 K-ASSAY® D-Dimer Reagent
46 00816426020221 KAI-040 KAI-040 For the quantitative determination of human insulin in serum and plasma by immun For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay. CFP Radioimmunoassay, Immunoreactive Insulin 1 K-ASSAY® Insulin Reagent
47 00816426020207 KAI-033 KAI-033 For the quantitative determination of human C-reactive protein (CRP) in serum by For the quantitative determination of human C-reactive protein (CRP) in serum by immunoturbidimetric assay. DCK C-Reactive Protein, Antigen, Antiserum, And Control 2 K-ASSAY® CRP Reagent (L)
48 00816426020085 KAI-010 KAI-010 For the quantitative determination of human 4th complement component (Complement For the quantitative determination of human 4th complement component (Complement C4) in serum by immunoturbidimetric assay. DBI Complement C4, Antigen, Antiserum, Control 2 K-ASSAY® Complement C4 Reagent
49 00816426021396 KAI-300 KAI-300 For the quantitative determination of unsaturated iron binding capacity (UIBC) in serum. JMO Ferrozine (Colorimetric) Iron Binding Capacity 1 K-ASSAY® UIBC Reagent
50 00816426021327 K283C-4M K283C-4M For use as a consistent test sample of known concentration for monitoring assay For use as a consistent test sample of known concentration for monitoring assay conditions for beta-2 microglobulin. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 K-ASSAY® Beta-2 Microglobulin / Ferritin - Serum / Plasma Control
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20 08718734961499 Level 3 221.003.010 CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
21 08718734961482 Level 2 221.002.010 CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
22 08718734961475 Level 1 221.001.010 CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. CueSee® VeriSTAT QC EUROTROL B.V.
23 08718734961468 220.000.005 CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451 CueSee® VeriSTAT LVM EUROTROL B.V.
24 08718734960928 183.000.005 Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each Product is packaged in Eurotrol boxes, containing 5 ampules, one ampule of each level.It is a convenience kit for the purposes of UDI compliance because it contains 5 different levels that are packaged together for the convenience of the user and intended to remain packaged together and not replaced, substituted, repackaged, sterilized or otherwise processed or modified before being used by an end user. Therefore, the label of each individual vial within the container is not required to bear a UDI,provided that a UDI is available on the label affixed to the immediate container of the kit. Eurotrol EUROTROL B.V.
25 08718734960911 179.003.010 Eurotrol EUROTROL B.V.
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27 08718734960874 179.001.010 Eurotrol EUROTROL B.V.
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