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

    PMA: P940034 · Supplement: S010 · Decision May 25, 1999
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
    PMA Number
    P940034
    Supplement Number
    S010
    Advisory Committee
    Microbiology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 25, 1999
    Date Received
    May 12, 1999
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    30-day Notice for the following changes: revised performance specifications for specific materials and the addition of qualified vendors; and implementation of additional in-process qualification procedures for testing oligonucleo tide materials.