Other products from "INSTRUMENTATION LABORATORY COMPANY"
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
Other products with the same Product Code "GGP"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00859394006095 90-480 90-480 Protein S Kit 80-160 DET ThromboTek PSe R 2 DIAGNOSTICS, INC.
2 00855360006267 10826 10826 INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative d INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand Factor Activity (VWF:Act) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY OF THE TEST Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also known as the anti-hemophilic factor. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes von Willebrand disease. Von Willebrand Disease is characterized by a deficiency or defect of VWF. Greater than 70% of Von Willebrand disease patients have a type 1 deficiency while approximately 20% have a type II deficiency. The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative (functional) determinations to differentiate the two predominant subtypes of the disease, type I and type II. The classification of Von Willebrand disease into subtypes is important in determining the course of clinical treatment. PRINCIPLE OF THE TEST The REAADS VWF:Act assay is a sandwich ELISA. A monoclonal capture antibody specific for the portion of VWF which binds platelets is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells. The plates are washed to remove unbound proteins and other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in O.D. units with a spectrophotometer at 450 nm. Patient VWF:Act in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. Refer to Product Package Insert. REAADS von Willebrand Factor Activity Test Kit CORGENIX MEDICAL CORPORATION
3 00855360006038 034-001 034-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von WillebrandFactor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY THE TESTVon Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found incirculation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein alsoknown as the anti-hemophilic factor. These two proteins show distinct biochemical and functionalproperties as well as different antigenic determinants; their plasma levels may vary independently ofeach other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes VonWillebrand disease. VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of thegeneral population. Approximately 80% of Von Willebrand disease patients have a type I deficiency.The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative(functional) determinations.PRINCIPLE OF THE TESTREAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any availableVWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed toremove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradishperoxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unboundconjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogenperoxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in opticaldensity (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percentconcentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert. REAADS von Willebrand Factor Antigen Test Kit CORGENIX MEDICAL CORPORATION
4 00855360006021 035-001 035-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TESTProtein C deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. Patients with a congenital heterozygous deficiency may present with venous thrombosis in young adulthood, while patients with the rare homozygous deficiency present with massive thrombosis (purpura fulminans) during the neonatal period. The prevalence of Protein C deficiency in the general population has been estimated at 1 in 300. In younger patients (<40-45 years) with recurrent venous thrombosis, the frequency of Protein C deficiencies may be as high as 10 to 15%. A decreased Protein C activity in plasma may be the result of low concentrations and function (type I) or only low function (type II).PRINCIPLE OF THE TESTThe Protein C Antigen assay is a sandwich ELISA. A capture antibody specific for human Protein C is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound Protein C is quantitated using horseradish peroxidase (HRP) conjugated anti-human Protein C detection antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450nm. Protein C Antigen relative percent concentrations in patient plasma are determined against a curve prepared from the reference plasma provided with the kit.Refer to Product Package Insert. REAADS Protein C Test Kit CORGENIX MEDICAL CORPORATION
5 00855360006014 051-001 051-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE PROTEIN S TESTProtein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, down-regulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not.Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%. Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia, and various inflammatory syndromes. A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule.Refer to Product Package Insert. REAADS Monoclonal Free Protein S Antigen CORGENIX MEDICAL CORPORATION
6 00855360006007 036-001 036-001 INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative de INTENDED USEAn enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen in citrated human plasma. For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE PROTEIN S TESTProtein S is a vitamin K-dependent protein synthesized in the liver, vascular endothelium, and megakaryocytes, which plays an important physiologic role in the Protein C Anticoagulant System. This anticoagulant system is one of the major regulators of hemostasis by inhibiting clot formation and by promoting fibrinolysis. Protein S functions as a cofactor for activated Protein C on the vascular membrane to facilitate the degradation of clotting factors Va and VIIIa, downregulating clot formation. In normal plasma approximately 40% of Protein S circulates as a free molecule, while 60% is complexed with C4b, a plasma protein of the classical complement pathway. Only Free Protein S is functionally active and able to bind to activated Protein C, while the complexed form of Protein S is not.Protein S deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. The prevalence of Protein S deficiency has been estimated to be less than 1 case per 300 in the general population. Two-thirds of patients with a congenital deficiency of Protein S (levels less than 50% of normal) may present with venous thrombosis in young adulthood. In young patients (<35 years) with a history of thrombosis, the prevalence may be as high as 15 to 18%.7 Acquired Protein S deficiency may be seen during pregnancy, oral contraceptive or oral anticoagulant therapy, liver disease, diabetes mellitus, postoperative complications, septicemia and various inflammatory syndromes.8 A decreased Protein S activity in plasma may be the result of low concentrations or abnormal function of the Protein S molecule.Refer to Product Package Insert. REAADS Protein S Antigen Test kit CORGENIX MEDICAL CORPORATION
7 00850201006161 ACC-45 ACC-45 ACTICLOT C KIT BIOMEDICA ADI INC.
8 00850201006154 843L 843L ACTICLOT PROTEIN S BIOMEDICA ADI INC.
9 00850201006109 101201 101201 SPECTROLYSE PAI-1 BIOMEDICA ADI INC.
10 00850201006093 885 885 IMUBIND vWF ACTIVITY ELISA BIOMEDICA ADI INC.
11 00850201006048 822 822 IMUBIND PLASMA PAI-1 ELISA BIOMEDICA ADI INC.
12 00843876000558 CCCF08 CCCF08 CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantita CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2% citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use CRYOcheck Factor VIII Chromogenic PRECISION BIOLOGIC INC
13 00843876000503 CCIK08 The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction The CRYOcheck FVIII Inhibitor Kit is for clinical laboratory use in conjunction with a factor VIII activity assay to enable performance of a modified Nijmegen-Bethesda assay using 3.2% citrated human plasma. It enables the determination of a functional FVIII inhibitor titer to aid in the clinical management of congenital hemophilia A in individuals aged 2 years and older. CRYOcheck™ FVIII Inhibitor Kit PRECISION BIOLOGIC INC
14 00843876000497 CSD C & S Diluent PRECISION BIOLOGIC INC
15 00843876000428 CCS-30 CRYOcheck™ Clot S™ PRECISION BIOLOGIC INC
16 00843876000411 CCS-15 CRYOcheck™ Clot S™ PRECISION BIOLOGIC INC
17 00843876000404 CCC-30 CRYOcheck™ Clot C™ PRECISION BIOLOGIC INC
18 00843876000398 CCC-15 CRYOcheck™ Clot C™ PRECISION BIOLOGIC INC
19 00842768039522 10873458 OPGL07 For the quantitative determination of free protein S antigen in human plasma col For the quantitative determination of free protein S antigen in human plasma collected from venous blood samplesin 3.2 % sodium citrate tubes on the BCS XP System, the SYSMEX CS-2500 analyzer and the SYSMEX CS-5100 analyzer. INNOVANCE Free PS Ag SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
20 00842768038211 10714565 OUBD39 Determination of ristocetin co-factor activity of von Willebrand factor in human Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination BC von Willebrand Reagent SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
21 00842768011917 10446500 OUVV17 Quantative determination of protein C activity as an aid in the diagnosis of inh Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Berichrom® Protein C SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
22 00842768011900 10446499 OUVV15 Quantative determination of protein C activity as an aid in the diagnosis of inh Quantative determination of protein C activity as an aid in the diagnosis of inherited and acquired deficiencies Berichrom® Protein C SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
23 00842768011160 10446427 OUBU15 Quantative determination of a2-antiplasmin activity as an aid in the diagnosis o Quantative determination of a2-antiplasmin activity as an aid in the diagnosis of inherited or acquired deficiencies and in management of fibrinolytic therapy Berichrom® a2-Antiplasmin SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
24 00842768008641 10446185 OQYG11 Coagulation test for the quantitative determination of protein C activity in human plasma Protein C Reagent SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
25 00842768006678 10445968 OPAP03 Determination of the functional activity of protein S in human plasma Protein S Ac SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
26 00842768004032 10445729 B4238-40 Determination of Factor VIII (antihemophilic factor) activity in human plasma Factor VIII Chromogenic Assay SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
27 00811476010291 299-3 vW Reference Plasma Normal Chrono-log CHRONO-LOG CORP
28 00811476010161 299 Ristocetin Cofactor Assay Kit Chrono-log CHRONO-LOG CORP
29 00811476010130 299-5 Tris Buffered Saline Chrono-log CHRONO-LOG CORP
30 00811476010123 299-2 Lyophilized Human Platelets 6mL, TBS 12mL Chrono-log CHRONO-LOG CORP
31 00811476010017 299-4 vW Reference Plasma Deficient Chrono-log CHRONO-LOG CORP
32 00811476010000 299-1 Ristocetin 7.5 mg/Vial Chrono-log CHRONO-LOG CORP
33 13607450007258 00725 STA® - Deficient VIII DIAGNOSTICA STAGO
34 10888234500346 403596 403596 For Use with Factor VIII Antibody Screen Positive Control IMMUCOR GTI DIAGNOSTICS, INC.
35 10888234500339 403593 403593 For Use with Factor VIII Antibody Screen Negative Control IMMUCOR GTI DIAGNOSTICS, INC.
36 10888234500322 403591 403591 For Use with Factor VIII Antibody Screen Kit Control IMMUCOR GTI DIAGNOSTICS, INC.
37 10888234500001 F8S F8S The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immun The Factor VIII Antibody Screen is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect reactive with recombinant human factor VIII (FVIII) in human serum and plasma. Factor VIII Antibody Screen IMMUCOR GTI DIAGNOSTICS, INC.
38 10629009020009 FIX-AG 96 Test enzyme immunoassay kit for the determination of FIX Antigen VisuLize Factor FIX Antigen Kit AFFINITY BIOLOGICALS INC
39 10629009010000 FVIII-AG 96 Test enzyme immunoassay kit for the determination of FVIII Antigen VisuLize Factor FVIII Antigen Kit AFFINITY BIOLOGICALS INC
40 M52553730 5373 Ristocetin Cofactor Abnormal Control Plasma HELENA LABORATORIES CORPORATION
41 M52553720 5372 Helena Ristocetin - 10 mg/mL HELENA LABORATORIES CORPORATION
42 M52553710 5371 Lyophilized Platelets HELENA LABORATORIES CORPORATION
43 M52553700 5370 Ristocetin Cofactor Assay Kit HELENA LABORATORIES CORPORATION
44 M52553650 5365 Tris-Buffered Saline HELENA LABORATORIES CORPORATION
45 M52553630 5363 Free Protein S Reagent HELENA LABORATORIES CORPORATION
46 M52553610 5361 von Willebrand Factor Antigen Rocket Kit HELENA LABORATORIES CORPORATION
47 M52553600 5360 Rocket Stain HELENA LABORATORIES CORPORATION
48 M52553590 5359 Protein S Antigen Rocket Kit HELENA LABORATORIES CORPORATION
49 M52553580 5358 Tris-Tricine Buffer HELENA LABORATORIES CORPORATION
50 M52553570 5357 Protein C Antigen Rocket Kit HELENA LABORATORIES CORPORATION