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    K Number
    K050662
    Device Name
    QUANTA LITE SP100 ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2005-06-13

    (90 days)

    Product Code
    NUM
    Regulation Number
    866.5090
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    Product Code :

    NUM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-sp100 antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of primary biliary cirrhosis (PBC).
    Device Description
    The QUANTA Lite™ sp100 kit is an enzyme-linked immunosorbent assay (ELISA).
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