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510(k) Data Aggregation

    K Number
    K061842
    Device Name
    QUANTA LITE PBC SCREEN IGG/IGA ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2006-10-18

    (111 days)

    Product Code
    NRI, DBM, NUM
    Regulation Number
    866.5090
    Why did this record match?
    Product Code :

    NRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite™ PBC Screen IgG/IgA ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies, gp210 antibodies, and sp100 antibodies of the IgG and/or IgA class in human serum. The presence of mitochondrial, gp210, and sp100 antibodies of the IgG and/or IgA class can be used in conjunction with other clinical and laboratory findings to aid in the diagnosis of primary biliary cirrhosis.
    Device Description
    Not Found
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    K Number
    K040885
    Device Name
    QUANTA LITE GP210 ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2004-06-25

    (81 days)

    Product Code
    NRI
    Regulation Number
    866.5090
    Why did this record match?
    Product Code :

    NRI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-gp210 antibody of the IgG class in human serum. In an appropriate clinical context, results are intended to aid in the diagnosis of primary biliary cirrhosis (PBC).
    Device Description
    The QUANTA Lite™ gp210 kit is an enzyme-linked immunosorbent assay (ELISA).
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