BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    PMA: P940040 · Supplement: S008 · Decision Jan 11, 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 TEST
    PMA Number
    P940040
    Supplement Number
    S008
    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
    January 11, 2008
    Date Received
    May 7, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., PLEASANTON, CALIFORNIA FOR BULK POSITIVE CONTROL STOCK MANUFACTURING.

    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