BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VITEK 2 AST-GP Clindamycin

    Reg #: 1950204 · FEI: 1950204 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    61
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOMERIEUX, INC.
    Registration Number
    1950204
    FEI Number
    1950204
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    595 ANGLUM RD.
    City
    HAZELWOOD
    State
    MO
    ZIP
    63042
    Country
    US

    Regulatory Submissions

    PMA Number
    N50510

    Owner / Operator

    Firm Name
    BIOMERIEUX SA
    Operator Number
    8020790
    Address
    Chemin De L Orme
    City
    Marcy L Etoile
    State
    Rhone
    Postal Code
    69280
    Country
    FR

    Products

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

    Proprietary Names

    VITEK 2 AST-GP Clindamycin VITEK 2 AST-GN Ceftizoxime VITEK 2 AST-GN Ticarcillin/ Clavulanic Acid VITEK 2 AST-GP Oxacillin VITEK 2 AST-GP Levofloxacin VITEK 2 AST-GN Norfloxacin VITEK 2 AST-GP Rifampin VITEK 2 AST-GN Cefotetan VITEK 2 AST-GN Ticarcillin VITEK 2 AST-GP Ofloxacin VITEK 2 AST-GP Streptomycin, HL VITEK 2 AST-GN Tobramycin VITEK 2 AST-GP for S.pn Ceftriaxone VITEK 2 AST-GP Cefazolin VITEK 2 AST-GP Norfloxacin VITEK 2 AST-GP Penicillin G VITEK 2 AST-GP Gentamicin VITEK 2 AST-GN Cefepime VITEK 2 AST-GN Ciprofloxacin VITEK 2 AST-GN Trimeth./sulfa VITEK 2 AST-GN Imipenem VITEK 2 AST-GN Cefuroxime VITEK 2 AST-GN Amox/Clav VITEK 2 AST-GP Vancomycin VITEK 2 AST-GN Gentamicin VITEK 2 AST-GN Meropenem VITEK 2 AST-GP Sparfloxacin VITEK 2 AST-GN Cefotaxime VITEK 2 AST-GP for S.pn Penicillin G VITEK 2 AST-GN Tetracycline VITEK 2 AST-GP Amp/Sulbactam VITEK 2 AST-GN Amikacin VITEK 2 AST-GP for S.pn Trimeth./sulfa VITEK 2 AST-GN Aztreonam VITEK 2 AST-GN Amp/Sulbactam VITEK 2 AST-GP Erythromycin VITEK 2 AST-GP Ampicillin VITEK 2 AST-GN Cefalotin VITEK 2 AST-GN Ceftazidime VITEK 2 AST-GP for S.pn Vancomycin VITEK 2 AST-GP Nitrofurantoin VITEK 2 AST-GN Cefazolin VITEK 2 AST-GN Piperacillin VITEK 2 AST-GP for S.pn Chloramphenicol VITEK 2 AST-GP Tetracycline VITEK 2 AST-GP Ciprofloxacin VITEK 2 AST-GN Nalidixic Acid VITEK 2 AST-GP Chloramphenicol VITEK 2 AST-GN Pip/Tazob. VITEK 2 AST-GP for S.pn Cefotaxime VITEK 2 AST-GP for S.pn Ofloxacin VITEK 2 AST-GN Nitrofurantoin VITEK 2 AST-GN Levofloxacin VITEK 2 AST-GN Cefoxitin VITEK 2 AST-GN Ceftriaxone VITEK 2 AST-GP for S.pn Tetracycline VITEK 2 AST-GN Ampicillin VITEK 2 AST-GP Minocycline VITEK 2 AST-GP Gentamicin, HL VITEK 2 AST-GN Cefpodoxime VITEK 2 Antimicrobial Susceptibility Test Device (GN, GP, and GP for S.pn)

    Establishment Types

    Manufacture Medical Device