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510(k) Data Aggregation

    K Number
    K193115
    Device Name
    EUROIMMUN Anti-BP230-CF ELISA (IgG)
    Manufacturer
    Euroimmun US, Inc.
    Date Cleared
    2020-09-17

    (310 days)

    Product Code
    OEG
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    OEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-BP230-CF ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of immunoglobulin class IgG antibodies against BP230 in human serum and plasma (K3-EDTA, Li+heparin, Na+-citrate). It is used as an aid in the diagnosis of bullous pemphigoid, in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K083615
    Device Name
    EUROIMMUN ANTI BP 180-4X ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-03-16

    (98 days)

    Product Code
    OEG
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    OEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EUROIMMUN Anti-BP180-4X ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against BP180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.
    Device Description
    Not Found
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    K Number
    K071961
    Device Name
    MESACUP MODELS BP180 AND BP230 ELISA KITS
    Manufacturer
    MBL INTERNATIONAL CORPORATION
    Date Cleared
    2008-08-25

    (406 days)

    Product Code
    OEG, DBL
    Regulation Number
    866.5660
    Why did this record match?
    Product Code :

    OEG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MESACUP BP180 or BP230 TEST is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti BP180 or BP230 antibodies in human serum. The MESACUP TESTS are intended for in vitro diagnostic use as an aid in the diagnosis of bullous pemphigoid in conjunction with other laboratory and clinical findings. Patients with Bullous Pemphigoid are known to have either BP180 or BP230 or both types of antibodies in serum. It is recommended that each patient be tested for BP180 and BP230 antibodies.
    Device Description
    BP means Bullous pemphigoid. Bullous pemphigoid (BP) is a chronic blistering of the skin. It ranges from mildly itchy welts to severe blisters and infection, and may affect a small area of the body or be widespread. The vast majority of those affected are elderly, but it has been seen at all ages. It is an autoimmune disorder, meaning it is caused when the body's immune system malfunctions. The immune system is meant to defend the body against bacteria, viruses, and disease, but instead produces against healthy tissue, cells and organs. Some patients with BP have other autoimmune diseases such diabetes and rheumatoid arthritis. Various other factors have been reported to play a role in triggering BP. These include drugs (furosemide, penicillin's), mechanical trauma, and physical traumas (burns from radiation, sun or heat). The BP180 Elisa kit is designed to detect the BP180 protein. The related BP230 Elisa kit is designed to detect the autoantigen BP230, also known as bullous pemphigoid antigen.
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