BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Susceptibility Test Cards, Antimicrobial

    PMA: N50510 · Supplement: S080 · Decision Apr 14, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Susceptibility Test Cards, Antimicrobial
    Trade Name
    VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD
    PMA Number
    N50510
    Supplement Number
    S080
    Device Class
    FDA Class 2
    Product Code
    LTW
    Generic Name
    Susceptibility test cards, antimicrobial
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 14, 1998
    Date Received
    April 1, 1998
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of a limitation to use an alternative method to confirm results for the testing of Pseudomonas aeruginosa with the antibiotic cefepime. The device, as modified, will be marketed under the trade name Vitek Gram Negative Susceptibility Card in three concentrations (equivalent to 4, 8 and 16 ug/ml) and is indciated for the testing of rapidly growing aerobic and/or facultatively anaerobic gram negative bacilli.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTW Susceptibility Test Cards, Antimicrobial