BEUDAMED
    FDA Registration Active 🇫🇷 France

    BioFire COVID-19 Test

    Reg #: 9615778 · FEI: 1000351505 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BioMerieux SA
    Registration Number
    9615778
    FEI Number
    1000351505
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    PARC TECHNOLOGIQUE DELTA SUD
    City
    VERNIOLLE Ariege
    Country
    FR

    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
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR

    Proprietary Names

    BioFire COVID-19 Test SARS-COV-2 R-GENE BioFire Respiratory Panel 2.1 BioFire Respiratory Panel 2.1-EZ BioFire RP2.1 BioFire RP2.1-EZ

    Establishment Types

    Manufacture Medical Device