| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04250289503631 | 3514 | AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | MST | Antibodies, Gliadin | 2 | AESKULISA® DGP-G | |
| 2 | 04250289504591 | 30-7514US | 30-7514US | AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-G is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation. | MST | Antibodies, Gliadin | 2 | AESKULISA® DGP-G |
| 3 | 04250289504461 | 51.100.US | 51.100.US | AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytoplasmic autoantibodies in human serum. The assay is a tool in the differential diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren’s syndrome (SS), polymyositis and dermatomyositis. | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | AESKUSLIDES® ANA-HEp-2 |
| 4 | 04250289503105 | 7501US | 7501US | AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | MST | Antibodies, Gliadin | 2 | AESKULISA® Glia-A |
| 5 | 04250289501484 | 3501 | AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | MST | Antibodies, Gliadin | 2 | AESKULISA® Glia-A | |
| 6 | 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). | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | AESKULISA® ß2-Glyco-GM |
| 7 | 04250289502856 | 30-7501US | 30-7501US | AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-A is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgA antibodies against gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation. | MST | Antibodies, Gliadin | 2 | AESKULISA® Glia-A |
| 8 | 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. | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | AESKULISA® ß2-Glyco-GM |
| 9 | 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). | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | AESKULISA® ß2-Glyco-GM | |
| 10 | 04250289500005 | 51.100 | AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytoplasmic autoantibodies in human serum. The assay is a tool in the differential diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren’s syndrome (SS), polymyositis and dermatomyositis. | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | AESKUSLIDES® ANA-HEp-2 | |
| 11 | 04250289510394 | 53.100.US | AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay u AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum. | LSW | Anti-Dna Antibody, Antigen And Control | 2 | AESKUSLIDES nDNA (Crithidia luciliae) | |
| 12 | 04250289503501 | 30-7115US | 30-7115US | AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualita AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, PM-Scl, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren`s syndrome, polymyositis and dermatomyositis. 30'+30'+30' automation incubation. | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | AESKULISA® ANA-HEp-2 |
| 13 | 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). | MID | System, Test, Anticardiolipin Immunological | 2 | AESKULISA® Cardiolipin-GM | |
| 14 | 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. | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | AESKULISA® ß2-Glyco-A |
| 15 | 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). | MID | System, Test, Anticardiolipin Immunological | 2 | AESKULISA® Cardiolipin-GM |
| 16 | 04250289503020 | 7115US | 7115US | AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualita AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, PM-Scl, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren`s syndrome, polymyositis and dermatomyositis. | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | AESKULISA® ANA-HEp-2 |
| 17 | 04250289502955 | 7105US | 7105US | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® snRNP-C |
| 18 | 04250289500579 | 3115 | AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualita AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Each well is coated with lysed HEp2 cells. The test collectively detects, in one well, total ANAs against double stranded DNA (dsDNA), histones, SS-A (Ro), SS-B (La), Sm, snRNP/Sm, Scl-70, PM-Scl, Jo-1 and centromeric antigens along with sera positive for HEp2 immunofluorescence test (IFT). The assay is a tool in the diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren`s syndrome, polymyositis and dermatomyositis. | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | AESKULISA® ANA-HEp-2 | |
| 19 | 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. | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | AESKULISA® ß2-Glyco-A |
| 20 | 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. | MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 2 | AESKULISA® ß2-Glyco-A | |
| 21 | 04250289500470 | 3105 | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® snRNP-C | |
| 22 | 04250289503143 | 7507US | 7507US | AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly pu AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease. | NBT | Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae) | 2 | AESKULISA® ASCA-A |
| 23 | 04250289500548 | 3112 | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® Cenp-B | |
| 24 | 04250289503006 | 7112US | 7112US | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® Cenp-B |
| 25 | 04250289502979 | 7107US | 7107US | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® SS-A |
| 26 | 04250289502894 | 30-7507US | 30-7507US | AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly pu AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease. 30'+30'+30' automation incubation. | NBT | Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae) | 2 | AESKULISA® ASCA-A |
| 27 | 04250289501521 | 3507 | AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly pu AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing highly purified mannan for the quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The assay is highly specific and sensitive for Crohn`s disease. | NBT | Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae) | 2 | AESKULISA® ASCA-A | |
| 28 | 04250289500494 | 3107 | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® SS-A | |
| 29 | 04250289510387 | 54.051.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | AESKUSLIDES ANCA Formalin | |
| 30 | 04250289510363 | 54.101.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | AESKUSLIDES ANCA Formalin | |
| 31 | 04250289504843 | 30-7515US | 30-7515US | AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme im AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunoassay employs synthetic, deamidated gliadin-derived peptides for the combined semiquantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum.30'+30'+30' automation incubation. | MST | Antibodies, Gliadin | 2 | AESKULISA® DGP-Check |
| 32 | 04250289503112 | 7502US | 7502US | AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgG antibodies against Gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | MST | Antibodies, Gliadin | 2 | AESKULISA® Glia-G |
| 33 | 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). | MID | System, Test, Anticardiolipin Immunological | 2 | AESKULISA® Cardiolipin-Check | |
| 34 | 04250289502948 | 7104US | 7104US | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® U1-70 |
| 35 | 04250289502863 | 30-7502US | 30-7502US | AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgG antibodies against Gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'-30'-30' incubation time | MST | Antibodies, Gliadin | 2 | AESKULISA® Glia-G |
| 36 | 04250289501491 | 3502 | AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified a AESKULISA Glia-G is a solid phase enzyme immunoassay employing highly purified alphaGliadin for the quantitative and qualitative detection of IgG antibodies against Gliadin in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | MST | Antibodies, Gliadin | 2 | AESKULISA® Glia-G | |
| 37 | 04250289500463 | 3104 | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® U1-70 | |
| 38 | 04250289504584 | 30-7513US | 30-7513US | AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). 30'+30'+30' automation incubation. | MST | Antibodies, Gliadin | 2 | AESKULISA® DGP-A |
| 39 | 04250289503624 | 3513 | AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamida AESKULISA DGP-A is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the quantitative and qualitative detection of IgA antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | MST | Antibodies, Gliadin | 2 | AESKULISA® DGP-A | |
| 40 | 04250289503129 | 7503US | 7503US | The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the q The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgA antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | AESKULISA tTg-A New Generation |
| 41 | 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). | MID | System, Test, Anticardiolipin Immunological | 2 | AESKULISA® Cardiolipin-A |
| 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). | MID | System, Test, Anticardiolipin Immunological | 2 | AESKULISA® Cardiolipin-A | |
| 43 | 04250289502931 | 7103US | 7103US | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® ENA-6Pro |
| 44 | 04250289502870 | 30-7503US | 30-7503US | The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the q The AESKULISA tTg-A New generation is a solid phase enzyme immunoassay for the quantitative and qualitative detection of IgA antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. 30'+30'+30' automation incubation. | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | AESKULISA tTg-A New Generation |
| 45 | 04250289500456 | 3103 | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | AESKULISA® ENA-6Pro | |
| 46 | 04250289510370 | 54.050.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | AESKUSLIDES ANCA Ethanol | |
| 47 | 04250289510356 | 54.100.US | AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutro AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a substrate for the qualitative and semi-quantitative determination of anti-neutrophil cytoplasmic autoantibodies (ANCA) in human serum by manual microscopy or with the HELIOS® AUTOMATED IFA SYSTEM.This in vitro diagnostic assay is used as an aid for the diagnosis of ANCA-associated vasculitides (AAV) in conjunction with other clinical and laboratory findings.All suggested results obtained with the HELIOS AUTOMATED IFA SYSTEM must be confirmed by trained personnel. | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | AESKUSLIDES ANCA Ethanol | |
| 48 | 04250289504935 | 51.101.US | 51.101.US | AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | AESKUSLIDES® ANA-HEp-2 gamma |
| 49 | 04250289503679 | 3515 | AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, dea AESKULISA DGP-Check is a solid phase enzyme immunoassay employing synthetic, deamidated gliadin-derived peptides for the combined quantitative and qualitative detection of IgA and IgG antibodies against deamidated Gliadin-specific peptides (DGP) in human serum. The assay is a tool in the diagnosis of celiac disease (gluten-sensitive enteropathy). | MST | Antibodies, Gliadin | 2 | AESKULISA® DGP-Check | |
| 50 | 04250289503556 | 30-7303US | 30-7303US | AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified nati AESKULISA MPO is a solid phase enzyme immunoassay employing highly purified native myeloperoxidase (MPO) from human peripheral blood polymorphnuclear cells for the quantitative and qualitative detection of antibodies against MPO in human serum. Anti-MPO antibodies recognize specific conformational epitopes only accessible on native MPO. The assay is a tool in the differential diagnosis of autoimmune systemic vasculitis. 30'+30'+30' automation incubation. | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | AESKULISA® MPO |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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. | |
| 2 | 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. | |
| 3 | 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. | |
| 4 | 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. | |
| 5 | 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. | |
| 6 | 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. | |
| 7 | 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. | |
| 8 | 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. | |
| 9 | 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. | |
| 10 | 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. | |
| 11 | 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. | |
| 12 | 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. | |
| 13 | 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. | |
| 14 | 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. | |
| 15 | 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. | |
| 16 | 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. | |
| 17 | 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. | |
| 18 | 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. | |
| 19 | 08426950496960 | 0009802008 | 0009802008 | HemosIL AcuStar Anti-Cardiolipin IgM | HemosIL AcuStar Anti-Cardiolipin IgM | INSTRUMENTATION LABORATORY COMPANY |
| 20 | 08426950496953 | 0009802004 | 0009802004 | HemosIL AcuStar Anti-Cardiolipin IgG | HemosIL AcuStar Anti-Cardiolipin IgG | INSTRUMENTATION LABORATORY COMPANY |
| 21 | 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. | |
| 22 | 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. | |
| 23 | 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. | |
| 24 | 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. | |
| 25 | 07340058410400 | FCAR100T | FCAR100T | DIASTAT total anti-Cardiolipin | EURO-DIAGNOSTICA AB | |
| 26 | 07340058410233 | FCAR100M | FCAR100M | DIASTAT anti-Cardiolipin IgM | EURO-DIAGNOSTICA AB | |
| 27 | 07340058410196 | FCAR100G | FCAR100G | DIASTAT anti-Cardiolipin IgG | EURO-DIAGNOSTICA AB | |
| 28 | 07333066014739 | DECC055300 | DECC055300 | EliA Cardiolipin IgM Well | EliA Cardiolipin IgM Well | PHADIA AB |
| 29 | 07333066014722 | DECC055290 | DECC055290 | EliA Cardiolipin IgG Well | EliA Cardiolipin IgG Well | PHADIA AB |
| 30 | 07333066014715 | DECC055280 | DECC055280 | EliA Cardiolipin IgA Well | EliA Cardiolipin IgA Well | PHADIA AB |
| 31 | 07333066013183 | 83-0009-01 | 83-0009-01 | EliA APS Positive Control 2500/5000 | EliA APS Positive Control 2500/5000 | PHADIA AB |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 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 |
| 37 | 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 |
| 38 | 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 | |
| 39 | 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 | |
| 40 | 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 | |
| 41 | 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 |
| 42 | 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 |
| 43 | 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 |
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 00855360006069 | 13525 | 13525 | INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are auto antibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgG aCL concentrations expressed in GPL units. One GPL unit is equivalent to 1 μg/mL of an affinity purified standard IgG sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. | Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 49 | 00855360006052 | 026-001 | 026-001 | INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE IGA TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgA aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. The O.D. values of the controls and patient samples are multiplied by the conversion factor to obtain IgA aCL values, expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert. | REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) | CORGENIX MEDICAL CORPORATION |
| 50 | 00850487007517 | Cardiolipin G | Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |