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    K Number
    K024224
    Device Name
    LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
    Manufacturer
    BIO-RAD
    Date Cleared
    2003-01-15

    (23 days)

    Product Code
    DHN, DBE
    Regulation Number
    866.5100
    Why did this record match?
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    Matched: '866.5120'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The new Liquichek™ Anti-Smooth Muscle Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of smooth muscle autoantibodies.
    Device Description
    This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
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    K Number
    K021648
    Device Name
    QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
    Manufacturer
    INOVA DIAGNOSTICS, INC.
    Date Cleared
    2002-09-20

    (123 days)

    Product Code
    NJF
    Regulation Number
    866.5120
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    Matched: '866.5120'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum. Detection of these antibodies is an aid in diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis (AIH) and primary biliary cirrhosis (PBC).
    Device Description
    The QUANTA Lite™ Actin ELISA kit is an enzyme-linked immunosorbent assay (ELISA).
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