BEUDAMED
    FDA Registration Active 🇫🇷 France

    MONOLISA anti-HAV EIA on EVOLIS

    Reg #: 8023060 · FEI: 3003992026 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BIO-RAD
    Registration Number
    8023060
    FEI Number
    3003992026
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROUTE DE CASSEL
    City
    STEENVOORDE Nord
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K092355

    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
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Hepatitis A Test (Antibody And Igm Antibody) LOL

    Proprietary Names

    MONOLISA anti-HAV EIA on EVOLIS

    Establishment Types

    Manufacture Medical Device