| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00847865000758 | 6632440 | 6632440 | MMRV IgG Control Lot Data | OPL,LJY,LFY,LJB | Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zost Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
| 2 | 00847865000437 | 6631640 | 6631640 | ToRC IgG Control Lot Data | JJY | Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
| 3 | 00847865013017 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 4 | 00847865013000 | SW4.1V1 | 6652365A | Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 5 | 00847865012997 | SW4.1_1 | 6652165B | Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
| 6 | 00847865012980 | SW4.1V1 | 6652065B | Manual & CDs, APLS IgM IFU, SW4.1_v1 | MID,MSV | SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) | 2 | BioPlex 2200 |
| 7 | 00847865012973 | SW4.1V1 | 6651975B | APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
| 8 | 00847865012966 | SW4.1V1 | 6651965B | Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
| 9 | 00847865012614 | SW4.1_V1 | 6651260F | Manual & CDs, EBV IgG IFU, SW4.1v1 | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
| 10 | 00847865012607 | SW4.1_V1 | 6651270D | EBV IgG Assay Protocol File CD, SW4.1_v1, US | LSE | EPSTEIN-BARR VIRUS, OTHER | 1 | BioPlex 2200 |
| 11 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
| 12 | 00847865012522 | SW4_1 | 6651965A | Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
| 13 | 00847865012515 | SW4_1 | 6652065A | Manual & CDs, APLS IgM IFU, SW4_v1, US Only | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
| 14 | 00847865012508 | SW4_1 | 6651975A | APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 | MSV,MID | System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL | 2 | BioPlex 2200 |
| 15 | 00847865012331 | SW4.1_V2 | 6651170D | ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 | LLL,LKJ,LJM,MQA,LKO,LRM | EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTI EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL,ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS,ANTI-RIBOSOMAL P ANTIBODIES,ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL,ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL | 2 | BioPlex 2200 |
| 16 | 00847865011655 | 6653750 | 6653750 | 25-OH Vitamin D Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | BioPlex 2200 |
| 17 | 00847865011648 | 6633740 | 6633740 | 25-OH Vitamin D Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
| 18 | 00847865011631 | 6633730 | 6633730 | 25-OH Vitamin D Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
| 19 | 00847865011624 | 6633720 | 6633720 | 25-OH Vitamin D Lot Data | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
| 20 | 00847865011617 | 6633700 | 6633700 | 25-OH Vitamin D Calibrator Set | JIT | CALIBRATOR, SECONDARY | 2 | BioPlex 2200 |
| 21 | 00847865011358 | SW4V2 | 6651360F | Manual & CDs, EBV IgM IFU, SW4_v2 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
| 22 | 00847865011341 | 6651360G | 6651360G | Manual & CDs, EBV IgM IFU, SW4.1_v1 | LJN,KTN | ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS | 1 | BioPlex 2200 |
| 23 | 00847865011129 | SW4_1 | 6652360A | Manual & CDs, Celiac IgA and IgG IFU, SW4_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
| 24 | 00847865011105 | 6600306 | 6600306 | BioPlex® 2200 Manual Reagent Pack Piercer | MZF | Test, Hiv Detection | 2 | BioPlex® 2200 |
| 25 | 00847865011082 | SW4.1V1 | 6651860H | Manual & CDs, Vasculitis IFU, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
| 26 | 00847865011075 | SW4.1_1 | 6651665E | U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
| 27 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | LFX,LKQ,LFZ | ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
| 28 | 00847865010993 | SW4.1_V2 | 6653370E | HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2 | MYF,MXJ | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 | 2 | BioPlex 2200 |
| 29 | 00847865010986 | SW4.1_V1 | 6653270E | BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1 | JIX,NHX,JJY | CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP),Multi-analyte controls, all kinds (assayed) | 1 | BioPlex 2200 |
| 30 | 00847865010979 | SW4.1_V1 | 6652470D | MMRV IgG Assay Protocol File CD, SW4.1_v1 | LJY,LFY,OPL,LJB | ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT A ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,Enzyme linked immunoabsorbent assay, rubeola IgG | 1 | BioPlex 2200 |
| 31 | 00847865010962 | SW4.1v1 | 6652270B | Celiac IgG Assay Protocol File CD, SW4.1_v1 | MST,MVM | Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) | 2 | BioPlex 2200 |
| 32 | 00847865010955 | SW4.1 V1 | 6651870E | Vasculitis Assay Protocol File CD, SW4.1_v1 | MOB,MVJ | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) | 2 | BioPlex 2200 |
| 33 | 00847865010948 | SW4.1_V1 | 6651670H | ToRC IgG Assay Protocol File CD, SW4.1_v1 | OMI | Multiplex flow immunoassay, t.Gondii, rubella and cmv. | 2 | BioPlex 2200 |
| 34 | 00847865010924 | SW4.1_v1 | 6651470E | Syphilis IgG Assay Protocol File CD, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
| 35 | 00847865010917 | 6632220 | 6632220 | Celiac IgG Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
| 36 | 00847865010900 | 6632320 | 6632320 | Celiac IgA Calibrator Lot Data | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
| 37 | 00847865010894 | 6632240 | 6632240 | Celiac IgG Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
| 38 | 00847865010887 | 6632340 | 6632340 | Celiac IgA Control Lot Data | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
| 39 | 00847865010863 | 6652250 | 6652250 | Celiac IgG Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 40 | 00847865010856 | 6652350 | 6652350 | Celiac IgA Reagent Pack | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 41 | 00847865010627 | 6632230 | 6632230 | Celiac IgG Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
| 42 | 00847865010610 | 6632330 | 6632330 | Celiac IgA Control Set | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | BioPlex 2200 |
| 43 | 00847865010603 | 6632200 | 6632200 | Celiac IgG Calibrator Set, | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
| 44 | 00847865010597 | 6632300 | 6632300 | Celiac IgA Calibrator Set | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | BioPlex 2200 |
| 45 | 00847865010580 | SW4_v1 | 6652370A | Celiac IgA Assay Protocol File CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 46 | 00847865010573 | SW4_v1 | 6652270A | Celiac IgG Assay Protocol file CD, SW4_v1 | MVM,MST | Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin | 2 | BioPlex 2200 |
| 47 | 00847865006682 | SW4.1_V1 | 6651460F | Manual & CDs, Syphilis IgG IFU, SW4.1_v1 | LIP | ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM | 2 | BioPlex 2200 |
| 48 | 00847865004725 | SW4_V2 | 6653360E | Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2 | MXJ,MYF | Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 | 2 | BioPlex 2200 |
| 49 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | LFZ,LKQ,LFX | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALO ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA | 2 | BioPlex 2200 |
| 50 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | LKQ,LFX,LFZ | ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBE ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | 2 | BioPlex 2200 |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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. | |
| 2 | 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. | |
| 3 | 08426950496984 | 0009802016 | 0009802016 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | INSTRUMENTATION LABORATORY COMPANY |
| 4 | 08426950496977 | 0009802012 | 0009802012 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | INSTRUMENTATION LABORATORY COMPANY |
| 5 | 08426950496960 | 0009802008 | 0009802008 | HemosIL AcuStar Anti-Cardiolipin IgM | HemosIL AcuStar Anti-Cardiolipin IgM | INSTRUMENTATION LABORATORY COMPANY |
| 6 | 08426950496953 | 0009802004 | 0009802004 | HemosIL AcuStar Anti-Cardiolipin IgG | HemosIL AcuStar Anti-Cardiolipin IgG | INSTRUMENTATION LABORATORY COMPANY |
| 7 | 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. | |
| 8 | 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. | |
| 9 | 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. | |
| 10 | 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. | |
| 11 | 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. | |
| 12 | 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. | |
| 13 | 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. | |
| 14 | 07340058410400 | FCAR100T | FCAR100T | DIASTAT total anti-Cardiolipin | EURO-DIAGNOSTICA AB | |
| 15 | 07340058410233 | FCAR100M | FCAR100M | DIASTAT anti-Cardiolipin IgM | EURO-DIAGNOSTICA AB | |
| 16 | 07340058410196 | FCAR100G | FCAR100G | DIASTAT anti-Cardiolipin IgG | EURO-DIAGNOSTICA AB | |
| 17 | 07340058410158 | FBGP100 | FBGP100 | DIASTAT anti-B2-Glycoprotein-1 IgM | EURO-DIAGNOSTICA AB | |
| 18 | 07340058410141 | FBGP200 | FBGP200 | DIASTAT anti-B2 Glycoprotein-1 IgG | EURO-DIAGNOSTICA AB | |
| 19 | 07333066014760 | DECC055330 | DECC055330 | EliA ß2-Glycoprotein I IgM Well | EliA ß2-Glycoprotein I IgM Well | PHADIA AB |
| 20 | 07333066014753 | DECC055320 | DECC055320 | EliA ß2-Glycoprotein I IgG Well | EliA ß2-Glycoprotein I IgG Well | PHADIA AB |
| 21 | 07333066014746 | DECC055310 | DECC055310 | EliA ß2-Glycoprotein I IgA Well | EliA ß2-Glycoprotein I IgA Well | PHADIA AB |
| 22 | 07333066014739 | DECC055300 | DECC055300 | EliA Cardiolipin IgM Well | EliA Cardiolipin IgM Well | PHADIA AB |
| 23 | 07333066014722 | DECC055290 | DECC055290 | EliA Cardiolipin IgG Well | EliA Cardiolipin IgG Well | PHADIA AB |
| 24 | 07333066014715 | DECC055280 | DECC055280 | EliA Cardiolipin IgA Well | EliA Cardiolipin IgA Well | PHADIA AB |
| 25 | 07333066013183 | 83-0009-01 | 83-0009-01 | EliA APS Positive Control 2500/5000 | EliA APS Positive Control 2500/5000 | PHADIA AB |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 |
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 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 |
| 37 | 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 |
| 38 | 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 | |
| 39 | 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 | |
| 40 | 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 | |
| 41 | 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 | |
| 42 | 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 | |
| 43 | 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 | |
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 00855360006212 | 10238 | 10238 | INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aP INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Antiphospholipid antibodies are a heterogeneous group of immunoglobulins (IgG, IgM, IgA) that bind to several anionic phospholipids (e.g., cardiolipin, phosphatidylserine), to phospholipid-protein complexes, and to certain proteins in the absence of anionic phospholipids. The REAADS aPT ELISA test kit uses purified human prothrombin as antigen to detect IgG anti-prothrombin antibodies in human serum or citrated plasma in the absence of other exogenous cofactors or phospholipids. High serum or plasma levels of aPT antibodies may add valuable information in the laboratory assessment of antiphospholipid antibodies.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrators and controls are incubated in microwells coated with purified human prothrombin. After the removal of unbound proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the prothrombin bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells. Results are obtained by reading the O.D. of each test well in a spectrophotometer. Calibrator sera are provided with the IgG anti-prothrombin antibody concentration. The user will run a single point calibration, dividing the concentration value of the calibrator sera by the O.D. value of the calibrator providing a conversion factor. The O.D. values of the other samples are multiplied by the conversion factor to obtain IgG anti-prothrombin antibody concentrations in G units. Refer to Product Package Insert. | REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit | CORGENIX MEDICAL CORPORATION |
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |