BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

    PMA: P940034 · Supplement: S001 · Decision Apr 23, 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
    GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)
    PMA Number
    P940034
    Supplement Number
    S001
    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
    April 23, 1996
    Date Received
    February 23, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1)A COMPONENT (NALC) IN A LIQUID REAGENT (ENZYME DILUTION BUFFER) IS MOVED TO A LYOPHILIZED REAGENT (ENZYME REAGENT), RESULTING IN A STABILITY SHELF LIFE OF 1 YEAR FOR THE REAGENTS AND 1 YEAR FOR THE KIT; 2) ADD AN ADDITIONAL VENDOR OF REVERSE TRANSCRIPTASE; AND, 3) INSIGNIFICANT CHANGES TO THE PACKAGE INSERT

    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