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 "MSV"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 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): HemosIL AcuStar Anti-B2GPI Domain 1 INSTRUMENTATION LABORATORY COMPANY
2 08426951289271 701250 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibr 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibrator 1 3. 1 QUANTA Flash B2GP1 IgM Calibrator 2 QUANTA Flash® B2GP1 IgM Reagents INOVA DIAGNOSTICS, INC.
3 08426951289264 701245 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Calibrator 2 QUANTA Flash® B2GP1 IgG Reagents INOVA DIAGNOSTICS, INC.
4 08426951289257 701240 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibra 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2 QUANTA Flash® B2GP1 IgA Reagents INOVA DIAGNOSTICS, INC.
5 08426950601951 701188 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 T 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 15. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2 QUANTA Flash® B2GP1-Domain 1Reagents INOVA DIAGNOSTICS, INC.
6 08426950596820 701243 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibra 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibrator 1 3. 1 QUANTA Flash ß2GP1 IgA Calibrator 2 QUANTA Flash® β2GPI IgA Reagents INOVA DIAGNOSTICS, INC.
7 08426950595816 708665.10 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI IgG ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
8 08426950594659 708675.10 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgA ELISA Control4. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI IgA ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
9 08426950594543 708665.10L 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp) INOVA DIAGNOSTICS, INC.
10 08426950594529 708670.10L 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgM ELISA Control4. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator D8. 5 x1.2mL prediluted 2 GPI IgM ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA LITE® B2 GPI IgM ELISA Bulk Pack Kit (Lab Corp) INOVA DIAGNOSTICS, INC.
11 08426950594482 708675.10L 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) INOVA DIAGNOSTICS, INC.
12 08426950594475 701253 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibra 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibrator 1 3. 1 QUANTA Flash β2GP1 IgM Calibrator 2 QUANTA Flash® β2GPI IgM Reagents INOVA DIAGNOSTICS, INC.
13 08426950594420 701248 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2 QUANTA Flash® β2GPI IgG Reagents INOVA DIAGNOSTICS, INC.
14 08426950593157 708675 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI IgA INOVA DIAGNOSTICS, INC.
15 08426950496984 0009802016 0009802016 HemosIL AcuStar Anti-B2 Glycoprotein-I IgM HemosIL AcuStar Anti-B2 Glycoprotein-I IgM INSTRUMENTATION LABORATORY COMPANY
16 08426950496977 0009802012 0009802012 HemosIL AcuStar Anti-B2 Glycoprotein-I IgG HemosIL AcuStar Anti-B2 Glycoprotein-I IgG INSTRUMENTATION LABORATORY COMPANY
17 08426950485971 708670 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2GPI IgM ELISA Control4. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator A5. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator B6. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator C7. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator D8. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x10mL HRP IgM Conjugate, (goat), anti-human IgM12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI IgM ELISA INOVA DIAGNOSTICS, INC.
18 08426950454472 708660 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point4. 1x 1.2mL prediluted β2 GPI Screening Control5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI Screening ELISA INOVA DIAGNOSTICS, INC.
19 08426950451112 708665 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® β2GPI IgG ELISA INOVA DIAGNOSTICS, INC.
20 07340058410158 FBGP100 FBGP100 DIASTAT anti-B2-Glycoprotein-1 IgM EURO-DIAGNOSTICA AB
21 07340058410141 FBGP200 FBGP200 DIASTAT anti-B2 Glycoprotein-1 IgG EURO-DIAGNOSTICA AB
22 07333066014760 DECC055330 DECC055330 EliA ß2-Glycoprotein I IgM Well EliA ß2-Glycoprotein I IgM Well PHADIA AB
23 07333066014753 DECC055320 DECC055320 EliA ß2-Glycoprotein I IgG Well EliA ß2-Glycoprotein I IgG Well PHADIA AB
24 07333066014746 DECC055310 DECC055310 EliA ß2-Glycoprotein I IgA Well EliA ß2-Glycoprotein I IgA Well PHADIA AB
25 04250289503099 7215US 7215US AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-Check AESKU.DIAGNOSTICS GMBH & CO. KG
26 04250289503082 7206US 7206US AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-GM AESKU.DIAGNOSTICS GMBH & CO. KG
27 04250289503075 7205US 7205US AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 gly AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary andsecondary antiphospholipid syndrome. AESKULISA® ß2-Glyco-A AESKU.DIAGNOSTICS GMBH & CO. KG
28 04250289502849 30-7215US 30-7215US AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. AESKULISA® ß2-Glyco-Check AESKU.DIAGNOSTICS GMBH & CO. KG
29 04250289502832 30-7206US 30-7206US AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. AESKULISA® ß2-Glyco-GM AESKU.DIAGNOSTICS GMBH & CO. KG
30 04250289502825 30-7205US 30-7205US AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation. AESKULISA® ß2-Glyco-A AESKU.DIAGNOSTICS GMBH & CO. KG
31 04250289500951 3215 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-Check AESKU.DIAGNOSTICS GMBH & CO. KG
32 04250289500869 3206 AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-GM AESKU.DIAGNOSTICS GMBH & CO. KG
33 04250289500852 3205 AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. AESKULISA® ß2-Glyco-A AESKU.DIAGNOSTICS GMBH & CO. KG
34 00855360006236 11854 11854 INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibo INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed byoxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.SUMMARY AND EXPLANATION OF THE ASSAYThe antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such asSLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TESTThis test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) CORGENIX MEDICAL CORPORATION
35 00855360006199 13372 13372 INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to product package insert. Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
36 00855360006182 13371 13371 INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl.. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product package insert. Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
37 00855360006175 13370 13370 INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY AND EXPLANATION OF THE I TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome. PRINCIPLE OF THE TEST The test is s an indirect ELISA. Diluted serum/ plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units.. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
38 00855360006168 038-001 038-001 INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionicphospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
39 00855360006151 037-001 037-001 INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
40 00855360006144 039-001 039-001 INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
41 00847865012997 SW4.1_1 6652165B Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
42 00847865012980 SW4.1V1 6652065B Manual & CDs, APLS IgM IFU, SW4.1_v1 BioPlex 2200 BIO-RAD LABORATORIES, INC.
43 00847865012973 SW4.1V1 6651975B APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
44 00847865012966 SW4.1V1 6651965B Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
45 00847865012522 SW4_1 6651965A Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
46 00847865012515 SW4_1 6652065A Manual & CDs, APLS IgM IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
47 00847865012508 SW4_1 6651975A APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 BioPlex 2200 BIO-RAD LABORATORIES, INC.
48 00847865002998 SW4_1 6652165A Manual & CDs, APLS IgA IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
49 00847865000710 6652150 6652150 APLS IgA Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.
50 00847865000666 6652050 6652050 APLS IgM Reagent Pack BioPlex 2200 BIO-RAD LABORATORIES, INC.