BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

    Reg #: 3010770794 · FEI: 3010770794 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    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
    K213362

    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
    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays PMN
    Multiplex Nucleic Acid Detection System For Biothreat Agents QVR
    Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness QMV

    Proprietary Names

    BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel BioFire Global Fever Special Pathogens Panel

    Establishment Types

    Manufacture Medical Device