BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940034 · Supplement: S011 · Decision Nov 21, 2000
    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
    S011
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 21, 2000
    Date Received
    October 25, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATION OF THE ENZYME DILUTION BUFFER AND TENTATIE RECONSTITUTED STABILITY (PENDING COMPLETION OF REAL-TIME STUDIES) OF THE ENZYME REAGENT FOR 30 DAYS WITH AN ADDED PRECAUTION, AND OTHER MINOR CHANGES TO THE LABELING (INCLUDING CLARIFICATION OF CONTROL TESTING PROCEDURES).