BEUDAMED
    FDA PMA FDA Class 2 30-Day Notice Accepted 🇺🇸 United States

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    PMA: P940040 · Supplement: S010 · Decision Nov 25, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
    Trade Name
    AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST
    PMA Number
    P940040
    Supplement Number
    S010
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 25, 2008
    Date Received
    November 5, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REPLACEMENT OF TETRAZOLE, AN ACTIVATOR USED IN THE AUTOMATED DNA SYNTHESIS OF RMS OLIGONUCLEOTIDES USE IN THE AMPLICOR MYCOBACTERIUM TUBERCULOSIS (MTB) TEST WITH THE ACTIVATOR 4,5 DICYANOIMIDAZOLE (DCI).

    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