BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Hepatitis A Test (Antibody And Igm Antibody)

    PMA: P790019 · Supplement: S011 · Decision Feb 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Hepatitis A Test (Antibody And Igm Antibody)
    Trade Name
    ABBOTT AXSYM HAVAB-M 2.0
    PMA Number
    P790019
    Supplement Number
    S011
    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
    February 2, 2004
    Date Received
    June 9, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ABBOTT AXSYM HAVAB-M 2.0. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AXSYM HAVAB-M 2.0 AND IS INDICATED FOR THE QUALITATIVE DETECTION IF IGM ANTIBODY TO HEPATITIS A VIRUS (IGM ANTI-HAV) IN HUMAN SERUM OR PLASMA. A TEST FOR IGM ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF ACUTE OR RECENT HEPATITIS A VIRAL 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)