BEUDAMED
    FDA Registration Active 🇫🇷 France

    BIO-RAD

    Reg #: 8023060 · FEI: 3003992026 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    24
    Establishment Types
    2
    Classifications
    17

    Registration Details

    Registration Name
    BIO-RAD
    Registration Number
    8023060
    FEI Number
    3003992026
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ROUTE DE CASSEL
    City
    STEENVOORDE Nord
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K122187
    PMA Number
    BP140120

    Owner / Operator

    Firm Name
    BIO-RAD
    Operator Number
    8023061
    Address
    3 BOULEVARD RAYMOND POINCARE, --
    City
    MARNES-LA-COQUETTE
    State
    FR-NOTA
    Postal Code
    92430
    Country
    FR

    US Agent

    Business Name
    BIO-RAD LABORATORIES
    Contact Name
    DAVID BHEND
    Address
    14620 Ne North Woodinville Way
    City
    Woodinville
    State
    WA
    ZIP
    98072
    Country
    US
    Email
    [email protected]
    Phone
    425 2730193

    Products

    Device Name Product Code
    Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar JSO
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX
    System, Test, Carcinoembryonic Antigen DHX
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hepatitis A Test (Antibody And Igm Antibody) LOL
    Culture Media, Non-Selective And Differential JSH
    Culture Media, Selective And Differential JSI
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Reagents, Specific, Analyte MVU
    Antigen, Galactomannan, Aspergillus Spp. NOM
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Assay, Glycosylated Hemoglobin LCP
    Staphylococcus Aureus Protein A Insoluble LHJ
    Reagent, Coronavirus Serological QKO
    Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test QSU
    Enzyme Linked Immunoabsorption Assay, Treponema Pallidum LIP
    Test, Hiv Detection MZF

    Proprietary Names

    VRE Select (stool claim) ACCESS RUBELLA IGG ACCESS CEA MONOLISA anti-HAV EIA on EVOLIS Uriselect 4 CandiSelect SA Select PLATELIA Toxo IgM kit Anti-HIV Antibody ASR MONOLISA anti-HAV IgM EIA on EVOLIS Platelia Aspergillus Ag Hemoglobin Capillary Collection System ACCESS TOXO IgG PASTOREX STAPH-PLUS Platelia SARS COV 2 Total Ab Geenius HIV 1/2 Supplemental Assay MONOLISA ANTI-HAV IGM EIA ACCESS SYPHILIS ACCESS TOXO IGM II MONOLISA ANTI-HAV EIA ACCESS TOXO IgM II Geenius HIV 1/2 Supplemental Assays and Controls MRSASelect II ACCESS RUBELLA IgG

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)