BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOMERIEUX, INC.

    Reg #: 3025775667 · FEI: 3025775667 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    63
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIOMERIEUX, INC.
    Registration Number
    3025775667
    FEI Number
    3025775667
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1201 S 4800 W
    City
    Salt Lake City
    State
    UT
    ZIP
    84104
    Country
    US

    Regulatory Submissions

    510(k) Number
    K063597
    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
    Correspondent
    Nathan Hardesty

    Products

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

    Proprietary Names

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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198