BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

    PMA: P870049 · Supplement: S028 · Decision Jan 25, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
    Trade Name
    MICROSCAN RAPID FLUOROGENIC PANELS
    PMA Number
    P870049
    Supplement Number
    S028
    Device Class
    FDA Class 2
    Product Code
    LON
    Generic Name
    SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
    Regulation Number
    866.1645
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 25, 1999
    Date Received
    January 4, 1999
    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 for testing of Proteus mirabilis and Enterobacter spp. with the antibiotic Cefazolin in either the Minimal Inhibitory Concentration (MIC) or the Breakpoint Panels.

    Classifications

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

    Product Code Device Name
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation