BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940034 · Supplement: S009 · Decision Dec 1, 1998
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    AMPLIFED MYCOBACTERIUM TUBERCULOSIS DIRECTOR (MTD) TEST
    PMA Number
    P940034
    Supplement Number
    S009
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 1, 1998
    Date Received
    October 19, 1998
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional text under Warnings: "Sediments prepared using Alpha-Tec Systems, Inc. NAC-PAC(TM) XPR-plus(TM) A.F.B. Processing Buffer have been shown to interfere with amplification."