BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIOMERIEUX FRANCE

    Reg #: 9615755 · FEI: 3007808629 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    67
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    BIOMERIEUX FRANCE
    Registration Number
    9615755
    FEI Number
    3007808629
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5 RUE DE ACQUEDUCS
    City
    CRAPONNE Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K091025

    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 Floor
    City
    Hazelwood
    State
    MO
    ZIP
    63042
    Country
    US
    Email
    [email protected]
    Phone
    314 7318666

    Products

    Device Name Product Code
    Kit, Screening, Staphylococcus Aureus JWX
    Culture Media, Non-Selective And Non-Differential JSG
    Kit, Identification, Yeast JXB
    Kit, Identification, Enterobacteriaceae JSS
    Stains, Dye Solution LEE
    Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar JSO
    Culture Media, Selective Broth JSD
    Gbs Culture Media, Selective And Differential PQZ
    Culture Media, Selective And Differential JSI
    Discs, Strips And Reagents, Microorganism Differentiation JTO
    Kit, Screening, Urine JXA

    Proprietary Names

    Slidex Staph Plus ID 32 Staph API STAPH TRYPCASE SOYA BROTH 20TUBES OEM Microscan Broth ID 32 C Qualitest - Albicans API 20 C AUX ALBICANS ID2 Rapid 20 E API 20 NE API 20 E (100) API 20 E (25) ID Indole TDA Rapid ID 32 E kit RAL Stainer Fluo RAL kit RAL Stainer Cold ZN PREVI FLUO TB chromID VRE Agar Todd Hewitt + Antibiotics (TODD H-T) ChromID® Strepto B Agar CHROMID Candida Agar chromID P. aeruginosa agar NTM Elite agar chromID CARBA ChromID S. aureus Elite Agar chromID C. Difficile 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 CHROMID CARBA agar (CARB) ChromID MRSA Agar Bi-Plate chromID MRSA / chromID S. Aureus chromID CPS Elite CHROMID CPS ELITE / COL CNA chromID MRSA / chromID S. aureus chromID MRSA

    Establishment Types

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