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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
DSI+II
In Commercial Distribution

  • 10888234500193 ()
DSI+II

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
DonorScreen-HLA Class I and Class II assay is a qualitative Enzyme Linked Immunosorbent Assay (ELISA) for use on the Bio-Rad QuickStep instrument. DonorScreen-HLA Class I and Class II assay ELISA is designed to detect anti-HLA class I and class II antibodies in human serum or plasma of blood donors.
IMMUCOR GTI DIAGNOSTICS, INC.
303456
In Commercial Distribution

  • 10888234500186 ()
303456

  • HLA class I & II antibody screening IVD, kit, enzyme immunoassay (EIA)
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).
Aesku.Diagnostics GmbH & Co. KG
7215US
In Commercial Distribution

  • 04250289503099 ()
7215US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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).
Aesku.Diagnostics GmbH & Co. KG
7206US
In Commercial Distribution

  • 04250289503082 ()
7206US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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 and secondary antiphospholipid syndrome.
Aesku.Diagnostics GmbH & Co. KG
7205US
In Commercial Distribution

  • 04250289503075 ()
7205US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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.
Aesku.Diagnostics GmbH & Co. KG
30-7215US
In Commercial Distribution

  • 04250289502849 ()
30-7215US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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.
Aesku.Diagnostics GmbH & Co. KG
30-7206US
In Commercial Distribution

  • 04250289502832 ()
30-7206US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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.
Aesku.Diagnostics GmbH & Co. KG
30-7205US
In Commercial Distribution

  • 04250289502825 ()
30-7205US

  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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).
Aesku.Diagnostics GmbH & Co. KG
3215
In Commercial Distribution

  • 04250289500951 ()


  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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).
Aesku.Diagnostics GmbH & Co. KG
3206
In Commercial Distribution

  • 04250289500869 ()


  • Anticardiolipin-B2-glycoprotein I complex antibody IVD, kit, enzyme immunoassay (EIA)
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