BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIOMERIEUX SA

    Reg #: 8020790 · FEI: 1000611339 · Expires 2026
    View on FDA
    Products
    31
    Proprietary Names
    41
    Establishment Types
    5
    Classifications
    31

    Registration Details

    Registration Name
    BIOMERIEUX SA
    Registration Number
    8020790
    FEI Number
    1000611339
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CHEMIN DE L ORME
    City
    MARCY L ETOILE Rhone
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K101946

    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
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Antigen, Inflammatory Response Marker, Sepsis NTM
    Station, Pipetting And Diluting, For Clinical Use JQW
    Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use LXG
    Acute Kidney Injury Test System PIG
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX
    Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster LFY
    Multi-Analyte Controls Unassayed OHQ
    Reagents, Clostridium Difficile Toxin LLH
    Reagent, Borrelia Serological Reagent LSR
    Antigens, All Groups, Streptococcus Spp. GTY
    Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens PMT
    Enzyme Linked Immunoabsorbent Assay, Rubeola Igg LJB
    Antibody Igm,If, Cytomegalovirus Virus LKQ
    Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control DAP
    Radioimmunoassay, Thyroid-Stimulating Hormone JLW
    Fluorometric, Cortisol JFT
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    Enzyme Linked Immunoabsorbent Assay, Mumps Virus LJY
    Medical Device Data System OUG
    Antigen, C. Difficile MCB
    Radioimmunoassay, Progesterone JLS
    Radioimmunoassay, Estradiol CHP
    Helicobacter Pylori LYR
    Brain Trauma Assessment Test QAT
    Procalcitonin Assay PRI
    Radioimmunoassay, Luteinizing Hormone CEP
    Stains, Dye Solution LEE
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Visual, Pregnancy Hcg, Prescription Use JHI
    Slide Stainer, Immersion Type KIO

    Proprietary Names

    VIDAS TOXO IgG Avidity VIDAS B.R.A.H.M.S PCT easySTREAM Instrument PreviISOLA VIDAS 3 ASSAY DILUTION CUP VIDAS 3 SAMPLE TIP Dry Blood Spot Puncher VIDAS® NEPHROCHECK® VIDAS RUB IGG VIDAS VZG IGG Assay QCV - Quality Control VIDAS VIDAS CDA/B Assay VIDAS Lyme IgG SLIDEX STREPTO VIDAS MEASLES IGG ASSAY ENZYME LINKED IMMUNOA VIDAS CMV IGM Assay VIDAS D-DIMER Exclusion II VIDAS TOXO IGG II (TXG) Assay MODEL (TSH) VIDAS Thyroid Stimulating Hormone Free Diluent VIDAS CMV IGG Assay VIDAS® Lyme IgM VIDAS Mumps (IgG) (MPG) Assay APIWeb MYLA VIDAS® C. difficile GDH VIDAS PROGESTERONE (PRG) VIDAS Estradiol II (E2II) Assay VIDAS H. Pylori IGG (HPY) Assay, MO VIDAS TBI (GFAP, UCH-L1) VIDAS Toxoplasma Gondii IGM Assay VIDAS B.R.A.H.M.S. PCT (PCT) VIDAS Luteinizing Hormone Assay kit RAL Stainer Fluo RAL kit RAL Stainer Cold ZN PREVI FLUO TB VIDAS Follicle Stimulating Hormone VIDAS Human Chronic Gonadotropin RAL Stainer

    Establishment Types

    Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device