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    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    PMA: P940040 · Decision Nov 26, 1996
    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 (TM) MYCOBACTERIUM TUBERCULOSIS TEST
    PMA Number
    P940040
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 26, 1996
    Date Received
    December 22, 1994
    Expedited Review
    Y
    Docket Number
    97M-0125

    Advisory Committee Statement

    APPROVAL FOR THE AMPLICOR(R) MYCOBACTERIUM TUBERCULOSIS(MTB) TEST. THE DEVICE IS A TARGET AMPLIFIED IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVE DETECTION OF M.TUBERCULOSIS COMPLEX DNA IN CONCENTRATED SEDIMENTS PREPARED FROM SPUTUM (INDUCED OR EXPECTORATED), BRONCHIAL SPECIMENS INCLUDING BRONCHOALVEOLAR LAVAGES OR ASPIRATES, OR TRACHEAL ASPIRATES.

    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