Other products from "GENBIO"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00613745010069 800-1006 1006 10-fold concentrate of 0.01M PBS GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA 10x PBS
2 00613745000169 800-4032 4032 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay tha The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood. GRY Antigens, All, Leptospira Spp. 2 ImmunoDOT Leptospira IgM
3 00613745000152 800-4034 4034 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay tha The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood. GRY Antigens, All, Leptospira Spp. 2 ImmunoDOT Leptospira IgM
4 00613745054896 800-5489 5489 The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. LLL Extractable Antinuclear Antibody, Antigen And Control 2 ImmunoDOT Autoimmunity Panel 4
5 00613745054254 800-5425 5425 The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 4 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. LLL Extractable Antinuclear Antibody, Antigen And Control 2 ImmunoDOT Autoimmunity Panel 4
6 00613745039206 800-3920 3920 Substitute Negative Control for specimen. Otherwise follow the Procedure as desc Substitute Negative Control for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Test package insert. LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 2 ImmunoDOT Negative Control
7 00613745030906 800-3090 3090 The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) fo The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders. MID System, Test, Anticardiolipin Immunological 2 ImmunoWELL Cardiolipin (IgG) Test
8 00613745000046 800-4030 4030 The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay tha The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood. GRY Antigens, All, Leptospira Spp. 2 ImmunoDOT Leptospira IgM
9 00613745058894 800-5889 5889 The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories. JNL Immunochemical, Thyroglobulin Autoantibody 2 ImmunoDOT Thyroid Autoimmunity Panel
10 00613745058252 800-5825 5825 The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for The ImmunoDOT Thyroid Autoimmunity Panel is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against human thyroglobulin and human thyroid peroxidase (microsome) in serum and heparinized whole blood and is used as an aid in the diagnosis of thyroid disorders. This product is intended for use in physician offices and clinical laboratories. JNL Immunochemical, Thyroglobulin Autoantibody 2 ImmunoDOT Thyroid Autoimmunity Panel
11 00613745031101 800-3110 3110 The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the quali The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the qualitative and/or semi-quantitative detection of Borrelia burgdorferi total antibodies (IgG, IgM, and IgA) in serum and is used as an aid in the diagnosis of Lyme disease. LSR Reagent, Borrelia Serological Reagent 2 ImmunoWELL Borrelia (Lyme)
12 00613745030203 800-3020 3020 The ImmunoWELL TPO IgG Quantitative Test is a quantitative enzyme immunoassay (E The ImmunoWELL TPO IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroid peroxidase (microsome) in serum and is used as an aid in the diagnosis of thyroid disorders. JNL Immunochemical, Thyroglobulin Autoantibody 2 ImmunoWELL TPO IgG Quantitative Test
13 00613745012025 800-1202 1202 IgG conjugate for use with ImmunoFA Toxoplasma IgG kit. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgG Conjugate
14 00613745010052 800-1005 1005 10-fold concentrate of 0.01M PBS GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA 10x PBS
15 00613745000053 800-4040 4040 The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the dete The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the detection of antibodies to Salmonella (typhoid fever) for the serological confirmation of infections in serum, plasma or heparinized whole blood. This test is intended to be performed by trained laboratory personnel only. GOO Antisera, Fluorescent, All Globulins, Salmonella Spp. 2 ImmunoDOT Salmonella typhi
16 00613745051895 800-5189 5189 The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 2 ImmunoDOT Autoimmunity Panel 1
17 00613745051253 800-5125 5125 The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 2 ImmunoDOT Autoimmunity Panel 1
18 00613745050256 800-5025 5025 The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test The ImmunoDOT Borrelia (Lyme) test is an enzyme immunoassay (EIA) dot-blot test for the qualitative detection of Borrelia antibodies. Both species specific (anti-P39) and related Borrelia burgdorferi antibodies (IgG, IgM, and IgA) are detected in serum as an aid in the diagnosis of Lyme disease. LSR Reagent, Borrelia Serological Reagent 2 ImmunoDOT Borrelia Test
19 00613745030302 800-3030 3030 The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immu The ImmunoWELL Thyroglobulin IgG Quantitative Test is a quantitative enzyme immunoassay (EIA) for screening and detection of autoantibodies against human thyroglobulin in serum and is used as an aid in the diagnosis of thyroid disorders. JNL Immunochemical, Thyroglobulin Autoantibody 2 ImmunoWELL Thyroglobulin IgG Quantitative Test
20 00613745013411 800-1341 1341 Positive control for use with ImmunoFA Toxoplasma IgM kit. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgM Positive Control
21 00613745039183 800-3918 3918 Substitute Serum Control D for specimen. Otherwise follow the Procedure as descr Substitute Serum Control D for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Autoimmunity Test package insert. LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 2 ImmunoDOT Serum Control D
22 00613745039053 800-3905 3905 This serum control contains IgG antibodies specific to Borrelia burgdorferi, the This serum control contains IgG antibodies specific to Borrelia burgdorferi, the causative agent of Lyme Disease, and is to be used in conjunction with the appropriate ImmunoDOT Assay Test System. LSR Reagent, Borrelia Serological Reagent 2 ImmunoDOT Borrelia Positive Control
23 00613745012070 800-1207 1207 For use with ImmunoFA Toxoplasma kits GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma Slides
24 00613745012056 800-1205 1205 Positive control for use with ImmunoFA Toxoplasma IgG kit. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgG High Control
25 00613745012018 800-1201 1201 Toxoplasma Slides for use with ImmunoFA Toxoplasma kits GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma Slides
26 00613745012001 800-1200 1200 The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and t The ImmunoFA Toxo IgG Test is an immunofluorescence test for the detection and titration of IgG antibodies to Toxoplasma gondii in human serum. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgG
27 00613745039121 800-3912 3912 Thyroid Positive Control contains antibodies specific to human thyroid peroxidas Thyroid Positive Control contains antibodies specific to human thyroid peroxidase (TPO, microsome) and human thyroglobulin. This control is to be used in conjunction with the appropriate ImmunoDOT Assay Test System. JNL Immunochemical, Thyroglobulin Autoantibody 2 ImmunoDOT Thyroid Positive Control
28 00613745013008 800-1300 1300 The ImmunoFA Toxo IgM Test is an immunofluorescence test for the presumptive det The ImmunoFA Toxo IgM Test is an immunofluorescence test for the presumptive detection and titration of IgM antibodies to Toxoplasma gondii in human serum and is presumptive for the diagnosis of acute, recent, or reactivated T. gondii infection. It is intended that the ImmunoFA Toxo IgG Test be performed in conjunction with this assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgM
29 00613745012049 800-1204 1204 Positive Control for use with ImmunoFA Toxoplasma IgG kit. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgG Low Control
30 00613745013091 800-1309 1309 Conjugate for use with ImmunoFA Toxoplasma IgM kit. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgM Conjugate
31 00613745012032 800-1203 1203 Negative control for use with ImmunoFA Toxoplasma kits. GLZ Antigens, If, Toxoplasma Gondii 2 ImmunoFA Toxoplasma IgG Negative Control
32 00613745010250 800-1025 1025 Mounting fluid for use with ImmunoFA kits. ImmunoFA Mounting Fluid
Other products with the same Product Code "MID"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 00613745031002 800-3100 3100 The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) fo The ImmunoWELL Cardiolipin Antibody (IgM) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders. ImmunoWELL Cardiolipin (IgM) Test GENBIO
2 00613745030906 800-3090 3090 The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) fo The ImmunoWELL Cardiolipin Antibody (IgG) Test is an enzyme immunoassay (EIA) for the quantitative detection of antibodies to cardiolipin antigen in serum and is used as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders. ImmunoWELL Cardiolipin (IgG) Test GENBIO
3 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.
4 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.
5 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.
6 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.
7 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.
8 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.
9 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.
10 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.
11 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.
12 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.
13 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.
14 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.
15 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.
16 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.
17 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.
18 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.
19 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.
20 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.
21 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.
22 08426950496960 0009802008 0009802008 HemosIL AcuStar Anti-Cardiolipin IgM HemosIL AcuStar Anti-Cardiolipin IgM INSTRUMENTATION LABORATORY COMPANY
23 08426950496953 0009802004 0009802004 HemosIL AcuStar Anti-Cardiolipin IgG HemosIL AcuStar Anti-Cardiolipin IgG INSTRUMENTATION LABORATORY COMPANY
24 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.
25 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.
26 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.
27 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.
28 07340058410400 FCAR100T FCAR100T DIASTAT total anti-Cardiolipin EURO-DIAGNOSTICA AB
29 07340058410233 FCAR100M FCAR100M DIASTAT anti-Cardiolipin IgM EURO-DIAGNOSTICA AB
30 07340058410196 FCAR100G FCAR100G DIASTAT anti-Cardiolipin IgG EURO-DIAGNOSTICA AB
31 07333066014739 DECC055300 DECC055300 EliA Cardiolipin IgM Well EliA Cardiolipin IgM Well PHADIA AB
32 07333066014722 DECC055290 DECC055290 EliA Cardiolipin IgG Well EliA Cardiolipin IgG Well PHADIA AB
33 07333066014715 DECC055280 DECC055280 EliA Cardiolipin IgA Well EliA Cardiolipin IgA Well PHADIA AB
34 07333066013183 83-0009-01 83-0009-01 EliA APS Positive Control 2500/5000 EliA APS Positive Control 2500/5000 PHADIA AB
35 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
36 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
37 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
38 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
39 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
40 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
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 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
47 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
48 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
49 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
50 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