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    K Number
    K081248
    Device Name
    QUANTA LITE OMP PLUS ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2008-10-27

    (178 days)

    Product Code
    OKM
    Regulation Number
    866.5785
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    Product Code :

    OKM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite™ OMP Plus kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-OMP antibodies of the IgA class in human serum. It is intended to be used in conjunction with anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) IgG and/or IgA test systems. The presence of OMP (outer membrane proteins) IgA antibodies, used in conjunction with clinical findings and other laboratory tests, may aid in the diagnosis of patients with Crohn's disease.
    Device Description
    Not Found
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