BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940034 · Supplement: S006 · Decision Oct 30, 1997
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
    PMA Number
    P940034
    Supplement Number
    S006
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 30, 1997
    Date Received
    September 15, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for manufacturing facility relocation to 10210 Genetic Center Dr., San Diego, CA.