BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    PMA: P940034 · Decision Dec 15, 1995
    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(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
    PMA Number
    P940034
    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 (Reclassification)
    Decision Code
    APRL
    Decision Date
    December 15, 1995
    Date Received
    July 11, 1994
    Expedited Review
    Y
    Docket Number
    97M-0184

    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