BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FilmArray 2

    Reg #: 3010770794 · FEI: 3010770794 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BioFire Defense, LLC
    Registration Number
    3010770794
    FEI Number
    3010770794
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    79 W 4500 S Ste 14
    City
    Salt Lake City
    State
    UT
    ZIP
    84107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K143178

    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

    Products

    Device Name Product Code
    Instrumentation For Clinical Multiplex Test Systems NSU

    Proprietary Names

    FilmArray 2

    Establishment Types

    Repack or Relabel Medical Device