BEUDAMED
    FDA Registration Active 🇫🇷 France

    MONOLISA Anti-HAV EIA (EVOLIS)

    Reg #: 3035708936 · FEI: 3035708936 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Bio-Rad Service France SAS
    Registration Number
    3035708936
    FEI Number
    3035708936
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rue des Freres Lumiere
    City
    Mitry Mory Ile-de-France
    Country
    FR

    Regulatory Submissions

    510(k) Number
    K092355

    Owner / Operator

    Firm Name
    Bio-Rad Laboratories (Bio-Rad Services France)
    Operator Number
    10078397
    Address
    Rue Gustave Eiffel
    City
    MITRY-MORY
    State
    Ile-de-France
    Postal Code
    77290
    Country
    FR
    Correspondent
    Lucie Watremetz

    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 (EVOLIS)

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device