LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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
    Why did this record match?
    Product Code :

    NJF

    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).
    Ask a Question

    Page 1 of 1