No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08426951346462 | 0003310300 | 00003310300 | Avox-4 CO-Oximeter Control, Level 3 | JJY | Multi-analyte controls, all kinds (assayed) | Avox-4 CO-Oximeter Control - L3 | |
2 | 08426951298778 | 00009800015 | 00009800015 | 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Re 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): | MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | HemosIL AcuStar Anti-B2GPI Domain 1 |
3 | 08426951293742 | 00044000115 | 00044000115 | GEM ChemSTAT CVP 1, 10 ampoules x 1.8 mL | JJY | Multi-Analyte Controls, All Kinds (Assayed) | GEM ChemSTAT CVP 1 | |
4 | 08426950716419 | 0005312 | 0005312 | Barcode wand | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | Barcode wand |
5 | 08426950497974 | 00000280010 | 00000280010 | ACL TOP 700 | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | ACL TOP 700 |
6 | 08426951027477 | 00055415004XC | 00055415004XC | GEM 5000 BG COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, GEM 5000 BG COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG COOX (150 TEST) |
7 | 08426951027453 | 00055445011XC | 00055445011XC | GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG ISE GL COOX TBILI (450 TEST) |
8 | 08426951027361 | 00055360009XC | 00055360009XC | GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca+ GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG ISE COOX TBILI (600 TEST) |
9 | 08426950927990 | 00000280010R | 00000280010R | ACL TOP 700 (Refurbished) | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | ACL TOP 700 |
10 | 08426950807803 | 00055445009 | 00055445009 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, C GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/COOX/TBILI 450 TEST |
11 | 08426950807797 | 00055445008 | 00055445008 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, Me GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/COOX 450 TEST |
12 | 08426950807766 | 00055430011 | 00055430011 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, t GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 300 TEST |
13 | 08426950807728 | 00055430005 | 00055430005 | GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/COOX/TBILI 300 TEST |
14 | 08426950807643 | 00055407511 | 00055407511 | GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, t GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 75 TEST |
15 | 08426950784050 | 00000280035 | 00000280035 | ACL TOP 750 LAS | GKP | INSTRUMENT, COAGULATION, AUTOMATED | 2 | ACL TOP 750 LAS |
16 | 08426950632870 | 00020301300 | 00020301300 | HemosIL ReadiPlasTin (10 mL) | GJS | TEST, TIME, PROTHROMBIN | 2 | HemosIL ReadiPlasTin (10 mL) |
17 | 08426950580690 | 00020012800 | 00020012800 | HemosIL Factor VIII Deficient Plasma | GJT | PLASMA, COAGULATION FACTOR DEFICIENT | HemosIL Factor VIII Deficient Plasma | |
18 | 08426950574255 | 00097579000 | 00097579000 | HemosIL Chromogenic Optic test 160umol L | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | Chromogenic Optic 160 umol L |
19 | 08426950573500 | 00020301800 | 00020301800 | HemosIL Q.F.A. Thrombin (Bovine) - 2 mL | GIS | TEST, FIBRINOGEN | HemosIL Q.F.A. Thrombin (Bovine) - 2 mL | |
20 | 08426950566526 | 00020302000 | 00020302000 | HemosIL Protein S Activity | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | HemosIL Protein S Activity |
21 | 08426950554820 | 00027360008 | 00027360008 | GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, M GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Test 21DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG ISE COOX 600 TEST 21 DAY |
22 | 08426950554813 | 00027360004 | 00027360004 | GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Test 21DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG COOX 600 TEST 21 DAY |
23 | 08426950554707 | 00027407509 | 00027407509 | GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG ISE COOX BILI 75 TEST 30 DAY |
24 | 08426950543589 | 00027430008 | 00027430008 | GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, M GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG ISE COOX 300 TEST 30 DAY |
25 | 08426950513278 | 00027415004 | 00027415004 | GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG COOX 150 TEST 30 DAY |
26 | 08426950511694 | 00026360089 | 00026360089 | GEM Premier 3500 3000 iQM 2WK BG LYTES GL (600 TEST) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3500 3000 iQM BG LYTES GL (600 TEST) |
27 | 08426950511656 | 00026345084 | 00026345084 | GEM Premier 3500 3000 iQM 3WK BG HCT (450 TEST) | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3500 3000 iQM BG HCT (450 TEST) |
28 | 08426950497035 | 0009802200 | 0009802200 | HemosIL AcuStar System Rinse | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | 2 | HemosIL AcuStar System Rinse |
29 | 08426950497004 | 0009802108 | 0009802108 | HemosIL AcuStar Anti-Cardiolipin IgM Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HemosIL AcuStar Anti-Cardiolipin IgM Controls |
30 | 08426950496984 | 0009802016 | 0009802016 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | MSV | System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM |
31 | 08426950472490 | 00020300200 | 00020300200 | HemosIL LMW Heparin Controls | KFF | ASSAY, HEPARIN | 2 | HemosIL LMW Heparin Controls |
32 | 08426950453031 | 00020007900 | 00020007900 | HemosIL Homocysteine Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | HemosIL Homocysteine Controls |
33 | 08426950453154 | 00003315250 | 00003315250 | Multi-4 CO-Oximeter Control, Level 1 | JJY | Multi-analyte controls, all kinds (assayed) | Multi-4 CO-Oximeter Control, Level 1 | |
34 | 08426950446217 | 00024360084 | 00024360084 | GEM Premier 3000 iQM 2WK - BG HCT - 600 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 600 Tests |
35 | 08426950446194 | 00027430004 | 00027430004 | GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM 4000 PAK BG COOX 300 TEST 30 DAY |
36 | 08426950088554 | 06260032000 | 06260032000 | GEM Test Citrate PT Cartridges | JPA | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES | GEM Test Citrate PT Cartridges | |
37 | 08426950088189 | 00024407584 | 00024407584 | GEM Premier 3000 iQM 4WK - BG HCT - 75 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 75 Tests |
38 | 08426950088004 | 00024307589 | 00024307589 | GEM Premier 3000 iQM 3WK - BG HCT ELECT. GL - 75 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT ELECT. GL - 75 Tests |
39 | 08426950087960 | 00024307584 | 00024307584 | GEM Premier 3000 iQM 3WK - BG HCT - 75 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 75 Tests |
40 | 08426950082538 | 00024345004 | 00024345004 | GEM Premier 3000 3WK - BG HCT - 450 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 - BG HCT - 450 Tests |
41 | 08426950082491 | 00024315009 | 00024315009 | GEM Premier 3000 3WK - BG HCT ELECT. GL - 150 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 - BG HCT ELECT. GL - 150 Tests |
42 | 08426950082484 | 00024315007 | 00024315007 | GEM Premier 3000 3WK - BG HCT ELECT. - 150 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 - BG HCT ELECT. - 150 Tests |
43 | 08426950082453 | 00024360087 | 00024360087 | GEM Premier 3000 iQM 2WK - BG HCT ELECT. - 600 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT ELECT. - 600 Tests |
44 | 08426950082361 | 00024315084 | 00024315084 | GEM Premier 3000 iQM 3WK - BG HCT - 150 Tests | CHL | ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH | 2 | GEM Premier 3000 iQM - BG HCT - 150 Tests |
45 | 08426950075899 | 00029400100 | 00029400100 | Cuvettes (2400 cuvettes) | GKP | INSTRUMENT, COAGULATION, AUTOMATED | Cuvettes (2400 cuvettes) | |
46 | 08426950071068 | 00020003110 | 00020003110 | HemosIL Normal Control ASSAYED | GGN | PLASMA, COAGULATION CONTROL | HemosIL Normal Control ASSAYED | |
47 | 08426950070320 | 00020002700 | 00020002700 | HemosIL Free Protein S | GGP | TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY | 2 | HemosIL Free Protein S |
48 | 08426950010906 | 00003510000 | 00003510000 | Urine Standard, 100 Na 100K | JJO | FLAME EMISSION PHOTOMETER FOR CLINICAL USE | 1 | Urine Standard, 100 Na 100K |
49 | 08426951391615 | 0020500300 | 00020500300 | HemosIL D-Dimer HS 500 (XL) | DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 2 | HemosIL D-Dimer HS 500 |
50 | 08426951346455 | 0003310200 | 00003310200 | Avox-4 CO-Oximeter Control, Level 2 | JJY | Multi-analyte controls, all kinds (assayed) | Avox-4 CO-Oximeter Control - L2 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00816870020228 | TMC-300 | TMC-300 | Monobind Qsure Tumor Marker Control Set | MONOBIND, INC. | |
2 | 00816870020211 | HPC-300 | HPC-300 | Monobind Qsure H. Pylori Control Set | MONOBIND, INC. | |
3 | 00816870020204 | MC-300 | MC-300 | Monobind Qsure Maternal Control Set | MONOBIND, INC. | |
4 | 00816870020198 | TG-300 | TG-300 | Monobind Qsure Tg Control Set | MONOBIND, INC. | |
5 | 00816870020181 | TBG-300 | TBG-300 | Monobind Qsure TBG Control Set | MONOBIND, INC. | |
6 | 00816870020174 | AIT-101 | AIT-101 | Monobind Qsure Anti-Tg & Anti-TPO Control Set | MONOBIND, INC. | |
7 | 00816870020099 | ML-300 | ML-300B | Monobind Qsure Multi-Ligand Control Set | MONOBIND, INC. | |
8 | 00816784020307 | 2015-0072 | 2015-0072 | ACCURUN 119 Anti-Hepatitis B e Antigen 1 x 5.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
9 | 00816784020291 | 2015-0071 | 2015-0071 | ACCURUN 117 Hepatitis B e Antigen 1 x 5.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
10 | 00816776020520 | 186010252IVD | 186010252IVD | MassTrak™ Immunosuppressant Quality Control Set | MassTrak | WATERS TECHNOLOGIES CORPORATION |
11 | 00816776020438 | 186009312IVD | 186009312IVD | MassTrak™ Endocrine Steroid Quality Control Set | MassTrak | WATERS TECHNOLOGIES CORPORATION |
12 | 00816467020136 | Multi-Analyte Controls | 25000056 | Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG | FastPack® Control Kit | QUALIGEN INC. |
13 | 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. | K-ASSAY® Apo AI / B Control | KAMIYA BIOMEDICAL COMPANY, LLC |
14 | 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. | K-ASSAY® Apo AI / B Control | KAMIYA BIOMEDICAL COMPANY, LLC |
15 | 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. | K-ASSAY® Ferritin / IgE / Insulin Control, L3 | KAMIYA BIOMEDICAL COMPANY, LLC |
16 | 00816426021037 | K59C-L2 | K59C-L2 | 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. | K-ASSAY® Ferritin / IgE / Insulin Control, L2 | KAMIYA BIOMEDICAL COMPANY, LLC |
17 | 00816426021020 | K59C-L1 | K59C-L1 | 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. | K-ASSAY® Ferritin / IgE / Insulin Control, L1 | KAMIYA BIOMEDICAL COMPANY, LLC |
18 | 00816426020931 | K110C-2M | K110C-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. | K-ASSAY® Liquid Lipid Control | KAMIYA BIOMEDICAL COMPANY, LLC |
19 | 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. | K-ASSAY® Ferritin / IgE / Insulin Control | KAMIYA BIOMEDICAL COMPANY, LLC |
20 | 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. | K-ASSAY® ASO/RF/CRP Control | KAMIYA BIOMEDICAL COMPANY, LLC |
21 | 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. | K-ASSAY® ASO/RF/CRP Control | KAMIYA BIOMEDICAL COMPANY, LLC |
22 | 00816426020825 | K49C-4M | K49C-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. | K-ASSAY® Liquid ITA Control | KAMIYA BIOMEDICAL COMPANY, LLC |
23 | 00816426020818 | K49C-2M | K49C-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. | K-ASSAY® Liquid ITA Control | KAMIYA BIOMEDICAL COMPANY, LLC |
24 | 00812137012197 | L1 x 3mL, L2 x 3mL, L3 x 3mL | 502-160 | This product is intended for in-vitro use in the quality control of HDL, LDL, Ap This product is intended for in-vitro use in the quality control of HDL, LDL, Apolipoprotein A-1, Apolipoprotein B, and Lipopro-tein (a) methods on clinical chemistry systems. The Multi-Analyte Lipid Control Set is a set of three serum levels. These three levels are to be used exclusively with the CDS HDL Cholesterol Reagent, CDS LDL Cholesterol Reagent, (CDS 501-419 and CDS 501-420) which are assays for the quan-tification of various lipids and lipoproteins in human serum. | Multi-Analyte Lipid Control Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
25 | 00812137012135 | 10 x 5mL | 502-153 | The Chemistry Control Level II is to be used for monitoring the accuracy and pre The Chemistry Control Level II is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added. The constituents were adjusted to the levels listed in Expected Values. | Chemistry Control Level II Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
26 | 00812137012128 | 10 x 5mL | 502-152 | The Chemistry Control Level I is to be used for monitoring the accuracy and prec The Chemistry Control Level I is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added. | Chemistry Control Level I Set | CLINICAL DIAGNOSTIC SOLUTIONS, INC. |
27 | 00811727014153 | 13-C7591-CTL-5 | 13-C7591-CTL-5 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes.1x 5 ml | Pointe Scientific, Inc. Chem Ctl Level 2 | POINTE SCIENTIFIC, INC. |
28 | 00811727014146 | 13-C7590-CTL-5 | 13-C7590-CTL-5 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes.1x 5 ml | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
29 | 00811727011848 | L7580-18 | L7580-18 | Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced fr Pointe Scientific, Inc. Lipid Control Set are assayed Lipid Controls produced from fresh human sera to monitor the accuracy and precision of quantitative lipid determinations of human sera specimens.6 x 3 ml. | Pointe Scientfic, Inc. Lipid Controls | POINTE SCIENTIFIC, INC. |
30 | 00811727010971 | C7562-12 | C7562-12 | This CK-MB Isoenzyme Control has been assayed for CK-MB and is intended to be us This CK-MB Isoenzyme Control has been assayed for CK-MB and is intended to be used as a human serum control product for CK-MB determinations. | POINTE SCIENTIFIC CK-MB Controls | POINTE SCIENTIFIC, INC. |
31 | 00811727010735 | C7592-100 | C7592-100 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes. | POINTE SCIENTIFIC Chemistry Control, Level 1 & 2 | POINTE SCIENTIFIC, INC. |
32 | 00811727010728 | C7591-50 | C7591-50 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes. | POINTE SCIENTIFIC Chemistry Control, Level 2 | POINTE SCIENTIFIC, INC. |
33 | 00811727010711 | C7590-50 | C7590-50 | For in vitro diagnostic use only. The Chemistry Control is to be used for monito For in vitro diagnostic use only. The Chemistry Control is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. The assayed multi-analyte control product is packaged with one level of analytes. | POINTE SCIENTIFIC Chemistry Control, Level 1 | POINTE SCIENTIFIC, INC. |
34 | 00811727010070 | A7504-CTL | A7504-CTL | "For in vitro diagnostic use only.The Pointe Scientific, Inc. Ammonia / Alcohol "For in vitro diagnostic use only.The Pointe Scientific, Inc. Ammonia / Alcohol Control set is to be used for monitoring the accuracy and precision of various ammonia and / or ethanol assay methods and to validate quantitation of patient samples. The controls contain components of known concentrations and are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. (475 characters)" | POINTE SCIENTIFIC Ammonia/Alcohol Controls | POINTE SCIENTIFIC, INC. |
35 | 00695684710033 | 71003 | Tri-level, For use with qualitative hCG serum tests. | HCG SERUM CONTROLS | GERMAINE LABORATORIES, INC | |
36 | 00695684710026 | 71002 | Bi-level, For use with qualitative hCG urine tests. | HCG URINE CONTROLS | GERMAINE LABORATORIES, INC | |
37 | 00657498002377 | 3063-006 | 3063-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - High | STANBIO LABORATORY, L.P. |
38 | 00657498002360 | 3063-003 | 3063-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - High | STANBIO LABORATORY, L.P. |
39 | 00657498002353 | 3062-006 | 3062-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Normal | STANBIO LABORATORY, L.P. |
40 | 00657498002346 | 3062-003 | 3062-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Normal | STANBIO LABORATORY, L.P. |
41 | 00657498002339 | 3061-006 | 3061-006 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Low | STANBIO LABORATORY, L.P. |
42 | 00657498002322 | 3061-003 | 3061-003 | A single level reference control intended for use on Hemo Control Hemoglobin Mea A single level reference control intended for use on Hemo Control Hemoglobin Measuring system. | HGB Controls - Low | STANBIO LABORATORY, L.P. |
43 | 00657498002032 | 3060-101H | 3060-101H | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, High | STANBIO LABORATORY, L.P. |
44 | 00657498002025 | 3060-101N | 3060-101N | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, Normal | STANBIO LABORATORY, L.P. |
45 | 00657498002018 | 3060-101L | 3060-101L | A single level reference control intended for use on HemoPoint® H2 Hemoglobin te A single level reference control intended for use on HemoPoint® H2 Hemoglobin testing system. | Hgb Control, Low | STANBIO LABORATORY, L.P. |
46 | 00657498001431 | 3065-201 | 3065-201 | A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin t A bi-level reference control set intended for use on HemoPoint® H2 Hemoglobin testing system. | Bi-Level Hgb Controls | STANBIO LABORATORY, L.P. |
47 | 00657498001219 | G428-86 | G428-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | Ser-T-Fy 2, Level 2 Control | STANBIO LABORATORY, L.P. |
48 | 00657498001202 | G427-86 | G427-86 | Use as a control serum to monitor the accuracy and precision of manual and autom Use as a control serum to monitor the accuracy and precision of manual and automated methods used in clinical chemistry. | Ser-T-Fy 1, Level 1 Control | STANBIO LABORATORY, L.P. |
49 | 00657498001189 | 1235-305 | 1235-305 | For Use as hCG Pregnancy Controls in Qualitative Serum hCG Pregnancy Procedures. | hCG Tri-Level Serum Controls | STANBIO LABORATORY, L.P. |
50 | 00657498001172 | 1225-205 | 1225-205 | For Use as hCG Pregnancy Controls in Qualitative Urine hCG Pregnancy Procedures. | hCG Bi-Level Urine Controls | STANBIO LABORATORY, L.P. |