BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940034 · Supplement: S007 · Decision Sep 2, 1999
    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
    S007
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 2, 1999
    Date Received
    August 17, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modified stability testing specifications, and a modified quality control procedure for monitoring acceptability of specimen processing reagents. The supplement included a protocol for assessing effectiveness of user controls with rRNA controls and a stability testing protocol using the 15 minute selection time that were specific conditions for postapproval requirements described in the approval order for P940034/S004.