BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P940034 · Supplement: S012 · Decision Aug 30, 2001
    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
    S012
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 30, 2001
    Date Received
    March 2, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PACKAGE INSERT IN LIEU OF A POST-MARKETING STUDY. THE CHANGES INCLUDE ADDITION OF INTERPRETIVE CRITERIA FROM THE CENTER FOR DISEASE CONTROL AND PREVENTION'S JULY 7, 2000, MMWR "UPDATE: NUCLEIC ACID AMPLIFICATION TEST FOR TUBERCULOSIS" AND THE CHANGE OF A PRECAUTION STATEMENT CONCERNING NEGATIVE TEST RESULTS TO A WARNING STATEMENT. THESE CHANGES WILL BE PROVIDED IN A TECHNICAL BULLETIN THAT WILL ACCOMPANY THE PACKAGE INSERT FOR THE NEXT 4-6 MONTHS UNTIL THE NEXT PRINTING OF THE PACKAGE INSERT.