BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    Hepatitis A Test (Antibody And Igm Antibody)

    PMA: P790019 · Supplement: S017 · Decision Nov 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Hepatitis A Test (Antibody And Igm Antibody)
    Trade Name
    IMX HAVAB -M (LIST NUMBER 2263)
    PMA Number
    P790019
    Supplement Number
    S017
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 6, 2003
    Date Received
    October 8, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    DISCONTINUE THE USE OF REFERENCE PANEL 4 AND ELIMINATE ALL ASSOCIATED VALIDITY AND ACCEPTANCE CRITERIA FROM BOTH THE INCOMING ALKALINE PHOSPHATASE AND THE IMX HAVAB-M CONJUGATE CONCENTRATE TESTING.

    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)