BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIOMERIEUX SA

    Reg #: 9615754 · FEI: 3008237827 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    161
    Establishment Types
    2
    Classifications
    22

    Registration Details

    Registration Name
    BIOMERIEUX SA
    Registration Number
    9615754
    FEI Number
    3008237827
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3 ROUTE DE PORT MICHAUD
    City
    LA BALME LES GROTTES Isere
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K260447

    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

    US Agent

    Business Name
    BioMerieux, SA
    Contact Name
    Nathan Hardesty
    Address
    595 Anglum Rd, Bldg. 1, 2nd Flr.
    City
    Hazelwood
    State
    MO
    ZIP
    63042
    Country
    US
    Email
    [email protected]
    Phone
    314 7318666

    Products

    Device Name Product Code
    Manual Antimicrobial Susceptibility Test Systems JWY
    System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates PEX
    Gram Positive Identification Panel LQL
    Culture Media, Non-Selective And Differential JSH
    Susceptibility Test Plate, Antifungal NGZ
    Calculator/Data Processing Module, For Clinical Use JQP
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Kit, Identification, Enterobacteriaceae JSS
    Culture Media, General Nutrient Broth JSC
    Igg, Antigen, Antiserum, Control DEW
    Medical Device Data System OUG
    Discs, Elution LTX
    Discs, Strips And Reagents, Microorganism Differentiation JTO
    Kit, Screening, Staphylococcus Aureus JWX
    Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates QBN
    Kit, Identification, Glucose Nonfermenter JSW
    Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates PTJ
    Kit, Anaerobic Identification JSP
    Slide Stainer, Automated KPA
    Kit, Identification, Yeast JXB
    Stains, Microbiologic JTS
    Clinical Sample Concentrator JJH

    Proprietary Names

    ETEST Gepotidacin (GEP) VITEK® MS ETEST Trimeth./Sulphamethoxazole ETEST OFLOXACIN Rapid Coryne System for Ident. of Coryneform Bacteria VITEK 2 Gram Positive Identification (GP) ETEST MOXIFLOXACIN API M MEDIUM ETEST Meropenem/Vaborbactam ETEST Antifungal Susc. Testing Streptococcus spp. and Anaerobic Gram Negative Aerobic Bacteria, Bacteria ETEST FOSFOMYCIN ETEST AMOX./CLAV. ACID 2/1 ETEST SUBMISSION FOR IMIPENEM NSV2 instal DVD eM W7 easySTREAM NSV2 RP5800 Master ARGENE connect Goldmaster RP5810 V1 NucliSENTRAL OBSERVA ETEST CEFTRIAXONE Etest Ceftolozane/ Tazobactam (016-256 ?g/ml) ETEST TOBRAMYCIN 016-256 UG/ML AND 064-1024 UG/ML Etest Ceftaroline (002 - 32ug/ml) VITEK MS ETEST TETRACYCLINE ETEST TICARCILLIN/CLAVULANIC ACID 2 ETEST PIPERACILIN TAZOBACTAM 4 UG Etest Ceftazidime/Avibactam (CZA) (016 - 256 ?g/ml) VIDAS 3 MiniVIDAS Instrument ETEST Fosfomycin ETEST AMPICILLIN/SULBACTAM 2/1 ETEST Piperacillin/Tazobactam (P/T) Rapid 20 E API 20 NE API 20 E (100) API 20 E (25) ID Indole TDA Rapid ID 32 E ETEST VANCOMYCIN API 50 CHB MEDIUM API 50 CH API 50 CHL MEDIUM Multi. General Nutrient Broth ETEST CEFTAROLINE ETEST CEFTAZIDIME ETEST CIPROFLOXACIN ETEST Eravacycline (ERV) ETEST ERTAPENEM ETEST AZITHROMYCIN ETEST Voriconazole ETEST Doripenem - MIC at 002-32 ug/ml ETEST GEMIFLOXACIN VIDAS system VITEK Immunodiagnostic Assay System APIWeb MYLA ETEST Plazomicin (PLZ) ETEST Imipenem/Relebactam P. aeruginosa (IRPA) for HAEMOPHILUS & PNEUMOCOCCUS ETEST DAPTOMYCIN ETEST LEVOFLOXACIN ETEST QUINUPRISTIN/DALFOPRISTIN ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE ETEST CEFEPIME ETEST Telavancin (TLA) (002-32 ?g/mL) ETEST LINEZOLID ETEST Delafloxacin (DFX) ETEST Imipenem/Relebactam (IPR) API CORYNE REACTIFS VP1 VP2 4AMP API Reagents (Multiple) ZYM B X2 NIN X2 API RAPIDEC Staph VP1 VP2 Reagents API Strep, Coryne, Zym and NH VPA VPB Reagents Rapid ID32 Strep API LISTERIA API CAMPY API SUSP API ZYM HUILE DE PARAFFINE API RAPID ID 32 STREP REACTIFS NIT 1+NIT 2 4AMP PYZ 2 AMP API NACL 0.85% MCFARLAND STANDARD BCP POURPRE DE BROMOCRESOL1AMP EHR (EHRLICH) 1 AMP API 20 STREP REACTIFS VPA VPB 2AMP API NH NIN 2 AMP XYL (XYLENE) REACTIF TDA 2AMP API Mineral Oil ID COLOR CATALASE JAMES 2 AMP ZN (POUDRE DE ZINC) FB (FAST BLUE BB) 2 AMP ETEST ESBL TZ/TZL STRIP ETEST ESBL CT/CTL STRIP; Slidex Staph Plus ID 32 Staph API STAPH ETEST Aztreonam/Avibactam API OF MEDIUM RAPIDEC CARBA NP ETEST MINOCYCLINE RAPID ID32A API 20A ETEST AZTREONAM Previ Color Gram V2 Previ Color Gram SINGLE SAMP CHAMBERS FAST POLY-L-LYSINE SLIDES DUAL DUAL SAMP CHAMBERS FAST POLY-L-LYSINE SLIDES SINGLE DUAL SAMP CHAMBERS SLOW 30 SLIDES CAROUSEL SINGLE SAMP CHAMBERS SLOW 12 SLIDES CAROUSEL PREVI COLOR CYTOCENTRIFUGE ETEST FOR CEFUROXIME & CEPHALOTHIN ID 32 C Qualitest - Albicans API 20 C AUX ALBICANS ID2 FUCHSIN-A (NA) CRYSTAL VIOLET-C (NA) ACETONE SAFRANIN-A (NA) IODINE-B (NA) ACETONE FUCHSIN-A SAFRANIN-A (NA) VITEK MS Prime ETEST MOXIFLOXACIN 002-32 UG/ML Etest Ofloxacin NucliSENS easyMAG Instrument eMAG Tips 1000 microliters eMAG Instrument EASYMAG DISPOSABLE 384T EMAG® V1.2 UPDATE INSTALLER DVD EASYMAG RP5810 W7 DVD MASTER V2.1 EMAG® RP5810 W7 DVD MASTER V1.2 EMAG® Software V1.3 easyMAG® Software V2.1 EMAG® Software V1.4 ETEST BENZYLPENICILLIN ETEST (Multiple Antibiotics) ETEST CEFOTAXIME ETEST AMOXICILLIN ETEST CEFTIZOXIME ETEST CHLORAMPHENICAL ETEST® Sulbactam/Durlobactam (SUD)

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility