BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Susceptibility Test Cards, Antimicrobial

    PMA: N50510 · Supplement: S139 · Decision Jun 26, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Susceptibility Test Cards, Antimicrobial
    Trade Name
    VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE
    PMA Number
    N50510
    Supplement Number
    S139
    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
    June 26, 2000
    Date Received
    April 12, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE ANTIBIOTIC TRIMETHOPRIM/SULFAMETHOXAZOLE AT CONCENTRATIONS OF 2/38, 8/152, 16/304 AND 32/608 MICROGRAMS/ML TO THE VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST SYSTEM. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITEK(R) 2 S. PNEUMONIAE SUSCEPTIBILITY TEST CARDS FOR USE IN THE VITEK(R) 2 SYSTEM AND IS INDICATED FOR USE FOR THE SUSCEPTIBILITY TESTING OF STREPTOCOCCUS PNEUMONIAE TO TRIMETHOPRIM/SULFAMETHOXAZOLE IN THE RANGE OF <=0.5/9.5 TO >=16/304

    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