BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Hepatitis A Test (Antibody And Igm Antibody)

    PMA: P890014 · Supplement: S002 · Decision Sep 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Hepatitis A Test (Antibody And Igm Antibody)
    Trade Name
    DIASORIN ETI-HA-IGMK PLUS
    PMA Number
    P890014
    Supplement Number
    S002
    Device Class
    FDA Class 2
    Product Code
    LOL
    Generic Name
    Hepatitis a test (antibody and igm antibody)
    Regulation Number
    866.3310
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 16, 1998
    Date Received
    November 24, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change in the Enzyme tracer and Tracer Diluent from a IgG (sheep) anti-HAV-HRP to a Fab anti-HAV (Mab)-HRP; a chang ein the Positive Control material to a human source sera; the elimination of the mercury preservative in the reagents; a change in the incubation times from an overnight procedure to a four and one-half hour incubation; the addition of an indicator dye; and the addition of a Calibrator reagent. The device, as modified, will be marketed under the trade name DiaSorin ETI-HA-IGMK PLUS and is intended for use in the qualitative determination of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum or plasma. This assay is indicated for use as an aid in the diagnosis and monitoring of acute or recent hepatitis A virus infection.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOL Hepatitis A Test (Antibody And Igm Antibody)