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 | 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 |
15 | 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 |
16 | 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 |
17 | 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 | |
18 | 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 |
19 | 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 | |
20 | 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 | |
21 | 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 |
22 | 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 | |
23 | 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 |
24 | 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 |
25 | 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 |
26 | 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 | |
27 | 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 | |
28 | 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 | |
29 | 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 | |
30 | 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 |
31 | 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 |
32 | 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). | MID | System, Test, Anticardiolipin Immunological | 2 | AESKULISA® Cardiolipin-Check |
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 | 00817273020402 | 720-830 | "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
2 | 00816879020243 | FGA24 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgA antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgA | HYCOR BIOMEDICAL LLC | |
3 | 00816879020236 | FGA23 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgM antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgM | HYCOR BIOMEDICAL LLC | |
4 | 00816879020229 | FGA22 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgG antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgG | HYCOR BIOMEDICAL LLC | |
5 | B24235B2SHUE010 | 35-B2SHU-E01 | 35-B2SHU-E01 | Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employ Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I in human serum. | Anti-Beta 2 Glycoprotein Screen ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
6 | 08426951298778 | 00009800015 | 00009800015 | 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Re 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): | HemosIL AcuStar Anti-B2GPI Domain 1 | INSTRUMENTATION LABORATORY COMPANY |
7 | 08426951289271 | 701250 | 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibr 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibrator 1 3. 1 QUANTA Flash B2GP1 IgM Calibrator 2 | QUANTA Flash® B2GP1 IgM Reagents | INOVA DIAGNOSTICS, INC. | |
8 | 08426951289264 | 701245 | 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Calibrator 2 | QUANTA Flash® B2GP1 IgG Reagents | INOVA DIAGNOSTICS, INC. | |
9 | 08426951289257 | 701240 | 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibra 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2 | QUANTA Flash® B2GP1 IgA Reagents | INOVA DIAGNOSTICS, INC. | |
10 | 08426950601951 | 701188 | 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 T 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 15. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2 | QUANTA Flash® B2GP1-Domain 1Reagents | INOVA DIAGNOSTICS, INC. | |
11 | 08426950596820 | 701243 | 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibra 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibrator 1 3. 1 QUANTA Flash ß2GP1 IgA Calibrator 2 | QUANTA Flash® β2GPI IgA Reagents | INOVA DIAGNOSTICS, INC. | |
12 | 08426950595816 | 708665.10 | 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
13 | 08426950594659 | 708675.10 | 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgA ELISA Control4. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
14 | 08426950594543 | 708665.10L | 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
15 | 08426950594529 | 708670.10L | 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgM ELISA Control4. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator D8. 5 x1.2mL prediluted 2 GPI IgM ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgM ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
16 | 08426950594482 | 708675.10L | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
17 | 08426950594475 | 701253 | 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibra 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibrator 1 3. 1 QUANTA Flash β2GP1 IgM Calibrator 2 | QUANTA Flash® β2GPI IgM Reagents | INOVA DIAGNOSTICS, INC. | |
18 | 08426950594420 | 701248 | 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2 | QUANTA Flash® β2GPI IgG Reagents | INOVA DIAGNOSTICS, INC. | |
19 | 08426950593157 | 708675 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgA | INOVA DIAGNOSTICS, INC. | |
20 | 08426950496984 | 0009802016 | 0009802016 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | INSTRUMENTATION LABORATORY COMPANY |
21 | 08426950496977 | 0009802012 | 0009802012 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | INSTRUMENTATION LABORATORY COMPANY |
22 | 08426950485971 | 708670 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2GPI IgM ELISA Control4. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator A5. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator B6. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator C7. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator D8. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x10mL HRP IgM Conjugate, (goat), anti-human IgM12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgM ELISA | INOVA DIAGNOSTICS, INC. | |
23 | 08426950454472 | 708660 | 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point4. 1x 1.2mL prediluted β2 GPI Screening Control5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI Screening ELISA | INOVA DIAGNOSTICS, INC. | |
24 | 08426950451112 | 708665 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgG ELISA | INOVA DIAGNOSTICS, INC. | |
25 | 07340058410158 | FBGP100 | FBGP100 | DIASTAT anti-B2-Glycoprotein-1 IgM | EURO-DIAGNOSTICA AB | |
26 | 07340058410141 | FBGP200 | FBGP200 | DIASTAT anti-B2 Glycoprotein-1 IgG | EURO-DIAGNOSTICA AB | |
27 | 07333066014760 | DECC055330 | DECC055330 | EliA ß2-Glycoprotein I IgM Well | EliA ß2-Glycoprotein I IgM Well | PHADIA AB |
28 | 07333066014753 | DECC055320 | DECC055320 | EliA ß2-Glycoprotein I IgG Well | EliA ß2-Glycoprotein I IgG Well | PHADIA AB |
29 | 07333066014746 | DECC055310 | DECC055310 | EliA ß2-Glycoprotein I IgA Well | EliA ß2-Glycoprotein I IgA Well | PHADIA AB |
30 | 04250289503099 | 7215US | 7215US | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
31 | 04250289503082 | 7206US | 7206US | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG |
32 | 04250289503075 | 7205US | 7205US | AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 gly AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary andsecondary antiphospholipid syndrome. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
33 | 04250289502849 | 30-7215US | 30-7215US | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
34 | 04250289502832 | 30-7206US | 30-7206US | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG |
35 | 04250289502825 | 30-7205US | 30-7205US | AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
36 | 04250289500951 | 3215 | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG | |
37 | 04250289500869 | 3206 | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG | |
38 | 04250289500852 | 3205 | AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG | |
39 | 00855360006236 | 11854 | 11854 | INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibo INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed byoxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.SUMMARY AND EXPLANATION OF THE ASSAYThe antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such asSLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TESTThis test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. | Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) | CORGENIX MEDICAL CORPORATION |
40 | 00855360006199 | 13372 | 13372 | INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to product package insert. | Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
41 | 00855360006182 | 13371 | 13371 | INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl.. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product package insert. | Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
42 | 00855360006175 | 13370 | 13370 | INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY AND EXPLANATION OF THE I TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome. PRINCIPLE OF THE TEST The test is s an indirect ELISA. Diluted serum/ plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units.. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
43 | 00855360006168 | 038-001 | 038-001 | INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionicphospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
44 | 00855360006151 | 037-001 | 037-001 | INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | REAADS Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
45 | 00855360006144 | 039-001 | 039-001 | INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
46 | 00847865012997 | SW4.1_1 | 6652165B | Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
47 | 00847865012980 | SW4.1V1 | 6652065B | Manual & CDs, APLS IgM IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
48 | 00847865012973 | SW4.1V1 | 6651975B | APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
49 | 00847865012966 | SW4.1V1 | 6651965B | Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
50 | 00847865012522 | SW4_1 | 6651965A | Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |