BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Hepatitis A Test (Antibody And Igm Antibody)

    PMA: P790019 · Supplement: S008 · Decision Mar 27, 1997
    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 IMX(R) HAVAB(R)-M
    PMA Number
    P790019
    Supplement Number
    S008
    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 27, 1997
    Date Received
    January 31, 1997
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN THE REFERENCE PANEL, TO REMOVE THE IGM ANTI-HBC POSITIVE PLASMA AND THE RHEUMATOID FACTOR POSITIVE PLASMA MIXED WITH HIGH TITER ANTI-HAV IGG POSITIVE PLASMA

    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)