BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Hepatitis A Test (Antibody And Igm Antibody)

    PMA: P830018 · Supplement: S001 · Decision Mar 21, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Hepatitis A Test (Antibody And Igm Antibody)
    Trade Name
    HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM
    PMA Number
    P830018
    Supplement Number
    S001
    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
    March 21, 1990
    Date Received
    August 25, 1989
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    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)