BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Susceptibility Test Cards, Antimicrobial

    PMA: N50510 · Supplement: S107 · Decision Jan 21, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Susceptibility Test Cards, Antimicrobial
    Trade Name
    VITEK 2 GRAM NEGATIVE AST FOR NITROFURANTOIN
    PMA Number
    N50510
    Supplement Number
    S107
    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
    January 21, 2000
    Date Received
    August 25, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32, and 64 ug/ml to the Vitek 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the tradename Vitek 2 and is indicated for use in Vitek 2 Gram Negative Susceptibility Test Card for the susceptibility testing of gram negative isolates to nitrofurantoin in the range of <= 16 to >= 512ug/ml.

    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