BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    PMA: P940034 · Supplement: S017 · Decision Jul 18, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
    Trade Name
    GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD)
    PMA Number
    P940034
    Supplement Number
    S017
    Device Class
    FDA Class 2
    Product Code
    MWA
    Generic Name
    System, nucleic acid amplification, mycobacterium tuberculosis complex
    Regulation Number
    866.3372
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 18, 2007
    Date Received
    July 27, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO A QUALITY CONTROL RELEASE SPECIFICATION FOR THE ENZYME REAGENT, A COMPONENT OF THE MYCOBACTERIUM TUBERCULOSIS DIRECT (MTD) TEST.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWA System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex