BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FilmArray GI Panel for use with FilmArray Torch

    Reg #: 3002773840 · FEI: 3002773840 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BioFire Diagnostics, LLC
    Registration Number
    3002773840
    FEI Number
    3002773840
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    515 Colorow Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84108
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160459

    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
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH

    Proprietary Names

    FilmArray GI Panel for use with FilmArray Torch

    Establishment Types

    Manufacture Medical Device