| 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 | B24235CAAHUE010 | 35-CAAHU-E01 | 35-CAAHU-E01 | The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highl The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human Beta-2-glycoprotein I (Beta-2-GPI) for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and Beta-2-GPI which are only expressed when Beta-2-GPI interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjunction with other serological tests and clinical findings. | Anti-Cardiolipin-A ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 2 | 08426951289295 | 701230 | 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 | QUANTA Flash® aCL IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 3 | 08426951289288 | 701225 | 1. 1 QUANTA Flash aCL IgA Reagent Cartridge2. 1 QUANTA Flash aCL IgA Calibrator 1. 1 QUANTA Flash aCL IgA Reagent Cartridge2. 1 QUANTA Flash aCL IgA Calibrator 1 3. 1 QUANTA Flash aCL IgA Calibrator 2 | QUANTA Flash® aCL IgA Reagents | INOVA DIAGNOSTICS, INC. | |
| 4 | 08426951289240 | 701235 | 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2 | QUANTA Flash® aCL IgM Reagents | INOVA DIAGNOSTICS, INC. | |
| 5 | 08426950596813 | 701228 | 1 .1 QUANTA Flash aCL IgA Reagent Cartridge2.1 QUANTA Flash aCL IgA Calibrator 1 1 .1 QUANTA Flash aCL IgA Reagent Cartridge2.1 QUANTA Flash aCL IgA Calibrator 1 3.1 QUANTA Flash aCL IgA Calibrator 2 | QUANTA Flash® aCL IgA Reagents | INOVA DIAGNOSTICS, INC. | |
| 6 | 08426950595670 | 704625.10 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 10 bottles containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgG ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use.7. Phosphatidylserine IgG Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9.HRP Phosphatidylserine IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured red, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. | QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 7 | 08426950595601 | 704635.10 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4.PS Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 10 bottles containing 50mL of a 20-fold concentrated buffer for washing the wells. 6.Phosphatidylserine IgA ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use.7. Phosphatidylserine IgA Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP Phosphatidylserine IgA Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgA. Coloured green, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. | QUANTA Lite® Phosphatidylserine IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 8 | 08426950594901 | 704630.10 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 10 bottles containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgM ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use.7. Phosphatidylserine IgM Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP Phosphatidylserine IgM Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgM. Coloured blue, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. | QUANTA Lite® Phosphatidylserine IgM ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 9 | 08426950594666 | 708635.10 | 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgA III Control4. 5x 1.2mL prediluted ACA IgA III Calibrator A5. 5x 1.2mL prediluted ACA IgA III Calibrator B6. 5x 1.2mL prediluted ACA IgA III Calibrator C7. 5x 1.2mL prediluted ACA IgA III Calibrator D8. 5x 1.2mL prediluted ACA IgA III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL ACA IgA III Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ACA IgA III ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 10 | 08426950594635 | 708625.10 | 1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgG III Control4. 5x 1.2mL prediluted ACA IgG III Calibrator A5. 5x 1.2mL prediluted ACA IgG III Calibrator B6. 5x 1.2mL prediluted ACA IgG III Calibrator C7. 5x 1.2mL prediluted ACA IgG III Calibrator D8. 5x 1.2mL prediluted ACA IgG III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL ACA IgG III Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ACA IgG III ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 11 | 08426950594536 | 708630.10 | 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgM III Control4. 5x 1.2mL prediluted ACA IgM III Calibrator A5. 5x 1.2mL prediluted ACA IgM III Calibrator B6. 5x 1.2mL prediluted ACA IgM III Calibrator C7. 5x 1.2mL prediluted ACA IgM III Calibrator D8. 5x 1.2mL prediluted ACA IgM III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL HRP ACA IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ACA IgM III ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 12 | 08426950594178 | 708635.10L | 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgA III Control4. 5x 1.2mL prediluted ACA IgA III Calibrator A5. 5x 1.2mL prediluted ACA IgA III Calibrator B6. 5x 1.2mL prediluted ACA IgA III Calibrator C7. 5x 1.2mL prediluted ACA IgA III Calibrator D8. 5x 1.2mL prediluted ACA IgA III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL ACA IgA III Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® ACA IgA III ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 13 | 08426950594123 | 708625.10L | 1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgG III Control4. 5x 1.2mL prediluted ACA IgG III Calibrator A5. 5x 1.2mL prediluted ACA IgG III Calibrator B6. 5x 1.2mL prediluted ACA IgG III Calibrator C7. 5x 1.2mL prediluted ACA IgG III Calibrator D8. 5x 1.2mL prediluted ACA IgG III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL ACA IgG III Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® ACA IgG III ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 14 | 08426950594062 | 708630.10L | 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgM III Control4. 5x 1.2mL prediluted ACA IgM III Calibrator A5. 5x 1.2mL prediluted ACA IgM III Calibrator B6. 5x 1.2mL prediluted ACA IgM III Calibrator C7. 5x 1.2mL prediluted ACA IgM III Calibrator D8. 5x 1.2mL prediluted ACA IgM III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL HRP ACA IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® ACA IgM III ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 15 | 08426950593430 | 704630 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgM ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 MPS U/mL. Ready to use.7. Phosphatidylserine IgM Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP Phosphatidylserine IgM Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgM. Coloured blue, ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. | QUANTA Lite® Phosphatidylserine IgM ELISA | INOVA DIAGNOSTICS, INC. | |
| 16 | 08426950593294 | 704635 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgA ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 APS U/mL. Ready to use.7. Phosphatidylserine IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP Phosphatidylserine IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Coloured green, ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. | QUANTA Lite® Phosphatidylserine IgA ELISA | INOVA DIAGNOSTICS, INC. | |
| 17 | 08426950593249 | 704625 | 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgG ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use.7.Phosphatidylserine IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP Phosphatidylserine IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured red, ready to use.10 TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use.11 HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. | QUANTA Lite® Phosphatidylserine IgG ELISA | INOVA DIAGNOSTICS, INC. | |
| 18 | 08426950544210 | 701238 | 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2 | QUANTA Flash® aCL IgM Reagents | INOVA DIAGNOSTICS, INC. | |
| 19 | 08426950544203 | 701233 | 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 | QUANTA Flash® aCL IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 20 | 08426950496960 | 0009802008 | 0009802008 | HemosIL AcuStar Anti-Cardiolipin IgM | HemosIL AcuStar Anti-Cardiolipin IgM | INSTRUMENTATION LABORATORY COMPANY |
| 21 | 08426950496953 | 0009802004 | 0009802004 | HemosIL AcuStar Anti-Cardiolipin IgG | HemosIL AcuStar Anti-Cardiolipin IgG | INSTRUMENTATION LABORATORY COMPANY |
| 22 | 08426950485988 | 708630 | 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA IgM III Control4. 1x 1.2mL prediluted ACA IgM III Calibrator A5. 1x 1.2mL prediluted ACA IgM III Calibrator B6. 1x 1.2mL prediluted ACA IgM III Calibrator C7. 1x 1.2mL prediluted ACA IgM III Calibrator D8. 1x 1.2mL prediluted ACA IgM III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x concentrate11. 1x 10mL HRP IgM Conjugate, (goat), anti-human IgM12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ACA IgM III | INOVA DIAGNOSTICS, INC. | |
| 23 | 08426950472773 | 708625 | 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA IgG III Control4. 1x 1.2mL prediluted ACA IgG III Calibrator A5. 1x 1.2mL prediluted ACA IgG III Calibrator B6. 1x 1.2mL prediluted ACA IgG III Calibrator C7. 1x 1.2mL prediluted ACA IgG III Calibrator D8. 1x 1.2mL prediluted ACA IgG III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x concentrate11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ACA IgG III | INOVA DIAGNOSTICS, INC. | |
| 24 | 08426950454489 | 708620 | 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA III Decision Point4. 1x 1.2mL prediluted ACA III Screen Control5. 1x 50mL ACA III Sample Diluent6. 1x 50mL ACA III PBS Concentrate, 20x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® ACA Screen III | INOVA DIAGNOSTICS, INC. | |
| 25 | 08426950448389 | 708635 | 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA IgA III Control4. 1x 1.2mL prediluted ACA IgA III Calibrator A5. 1x 1.2mL prediluted ACA IgA III Calibrator B6. 1x 1.2mL prediluted ACA IgA III Calibrator C7. 1x 1.2mL prediluted ACA IgA III Calibrator D8. 1x 1.2mL prediluted ACA IgA III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x 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® ACA IgA III | INOVA DIAGNOSTICS, INC. | |
| 26 | 07340058410400 | FCAR100T | FCAR100T | DIASTAT total anti-Cardiolipin | EURO-DIAGNOSTICA AB | |
| 27 | 07340058410233 | FCAR100M | FCAR100M | DIASTAT anti-Cardiolipin IgM | EURO-DIAGNOSTICA AB | |
| 28 | 07340058410196 | FCAR100G | FCAR100G | DIASTAT anti-Cardiolipin IgG | EURO-DIAGNOSTICA AB | |
| 29 | 07333066014739 | DECC055300 | DECC055300 | EliA Cardiolipin IgM Well | EliA Cardiolipin IgM Well | PHADIA AB |
| 30 | 07333066014722 | DECC055290 | DECC055290 | EliA Cardiolipin IgG Well | EliA Cardiolipin IgG Well | PHADIA AB |
| 31 | 07333066014715 | DECC055280 | DECC055280 | EliA Cardiolipin IgA Well | EliA Cardiolipin IgA Well | PHADIA AB |
| 32 | 07333066013183 | 83-0009-01 | 83-0009-01 | EliA APS Positive Control 2500/5000 | EliA APS Positive Control 2500/5000 | PHADIA AB |
| 33 | 04260157080140 | ORG515S | ORG515S | Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. | ANTI-CARDIOLIPIN SCREEN | ORGENTEC DIAGNOSTIKA GMBH |
| 34 | 04260157080133 | ORG515A | ORG515A | Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. | ANTI-CARDIOLIPIN IgA | ORGENTEC DIAGNOSTIKA GMBH |
| 35 | 04260157080126 | ORG515 | ORG515 | Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measuremen Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. | ANTI-CARDIOLIPIN IgG/IgM | ORGENTEC DIAGNOSTIKA GMBH |
| 36 | 04250289503068 | 7204US | 7204US | AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly pu AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). | AESKULISA® Cardiolipin-GM | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 37 | 04250289503051 | 7203US | 7203US | AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly pur AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). | AESKULISA® Cardiolipin-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 38 | 04250289503044 | 7202US | 7202US | AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anticardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). | AESKULISA® Cardiolipin-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 39 | 04250289500845 | 3204 | AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly pu AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). | AESKULISA® Cardiolipin-GM | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 40 | 04250289500838 | 3203 | AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly pur AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). | AESKULISA® Cardiolipin-A | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 41 | 04250289500821 | 3202 | AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anticardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). | AESKULISA® Cardiolipin-Check | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 42 | 04048474035896 | EIA-3589 | EIA-3589 | Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. | Anti-Cardiolipin Screen ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 43 | 04048474035872 | EIA-3587 | EIA-3587 | Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measureme Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. | Anti-Cardiolipin IgG/IgM ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 44 | 00855360006113 | 13534 | 13534 | INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. 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 phosphatidylserine bound antibodies. Following another washing 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-phosphatidylserine (aPS) antibodies. Results are obtained by reading the Optical Density of each well in a spectrophotometer. Calibrator sera are provided with the IgG anti-phosphatidylserine antibody concentrations expressed in GPS (IgG aPS) units traceable to the reference preparations of the Louisville Antiphospholipid Laboratory Control and patient results are determined from the calibration curve. Refer to Package Insert. | Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 45 | 00855360006106 | 10206 | 10206 | INTENDED USEDetection and semi-quantitation of IgA anti-phosphatidylserine (aPS) INTENDED USEDetection and semi-quantitation of IgA anti-phosphatidylserine (aPS) antibodies as an aid for assessingthe risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders(anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TESTHigh 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. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia, and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. 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 phosphatidylserine bound antibodies. Following another washing 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 IgA Antiphosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. (optical density or absorbance) of each well in a spectrophotometer. IgA calibrator sera are provided, expressed as APS (IgA anti-phosphatidylserine) units. Control and patient results are determined from the calibration curve. Refer to Package Insert. | REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
| 46 | 00855360006090 | 030-001 | 030-001 | INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE ANTI-PHOSPHATIDYLSERINE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG or IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Two enzyme-conjugated antibody solutions are provided, one specific for human IgG antibodies and one specific for human IgM antibodies. Following another washing 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-phosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided for both IgG and IgM antibody concentrations expressed in GPS or MPS units. Control and patient results are determined from the calibration curve. Refer to Package Insert. | REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
| 47 | 00855360006083 | 13530 | 13530 | INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 IgA aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert. | Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 48 | 00855360006076 | 13529 | 13529 | INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgM labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgM aCL concentrations expressed in MPL units. One MPL unit is equivalent to 1 μg/mL of an affinity purified standard IgM sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. | Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 49 | 00855360006069 | 13525 | 13525 | INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are auto antibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgG aCL concentrations expressed in GPL units. One GPL unit is equivalent to 1 μg/mL of an affinity purified standard IgG sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. | Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 50 | 00855360006052 | 026-001 | 026-001 | INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE IGA TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 IgA aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. The O.D. values of the controls and patient samples are multiplied by the conversion factor to obtain IgA aCL values, expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert. | REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) | CORGENIX MEDICAL CORPORATION |