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 00816426021631 K310C-2M K310C-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 Apolipoprotein AI and B. JJY Multi-Analyte Controls, All Kinds (Assayed) 1 K-ASSAY® Apo AI / B Control
35 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
36 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
37 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
38 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
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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1 08426951126538 0009800131 00009800131 1. Low HIT Control (Cat. No. 00009800132)2. High HIT Control (Cat. No. 00009800133): HemosIL Acustar HIT Controls INSTRUMENTATION LABORATORY COMPANY
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29 07640175460020 502-22 502-22 Control plasma for assays aimed to determine the functional phenotype for activa Control plasma for assays aimed to determine the functional phenotype for activated protein C resistance caused by the Factor V Leiden mutation (FV:Q506). Pefakit DSM NUTRITIONAL PRODUCTS AG ZWEIGNIEDERLASSUNG PENTAPHARM
30 04260160470587 delta System (US/CA) 201001 The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. ROTEM® TEM INNOVATIONS GMBH
31 04260160470112 ROTROL P 503-25-US, 503-25 ROTROL P is a quality control material for monitoring accuracy and precision of ROTROL P is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. ROTEM® TEM INNOVATIONS GMBH
32 04260160470105 ROTROL N 503-24-US, 503-24 ROTROL N is a quality control material for monitoring accuracy and precision of ROTROL N is a quality control material for monitoring accuracy and precision of tests carried out on the ROTEM® delta Thromboelastometry System. For in vitro diagnostic use only. ROTEM® TEM INNOVATIONS GMBH
33 04260160470099 star-tem® 20 503-10-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve – clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The star-tem® reagent is intended for use as recalcification reagent in the NATEM and INTEM assay on the ROTEM® delta. The corresponding assays are described in the NATEM assay application sheet and in the Instructions for Use of the in-tem® reagent (REF 503-02-US), resp. ROTEM® TEM INNOVATIONS GMBH
34 04260160470082 hep-tem® 503-09-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environ-ment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The hep-tem® assay is a semi-quantitative in vitro diagnostic assay used to inactivate heparin in patients receiving unfractionated heparin on the ROTEM® delta. To monitor the coagulation process citrated whole blood specimens are used. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). ROTEM® TEM INNOVATIONS GMBH
35 04260160470044 in-tem® 503-02-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.The in-tem® assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the intrinsic pathway in citrated whole blood specimens on the ROTEM® delta. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). ROTEM® TEM INNOVATIONS GMBH
36 04260160470020 delta System 200100-US The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a l The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively. ROTEM® TEM INNOVATIONS GMBH
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