BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioFire Defense, LLC

    Reg #: 3010770794 · FEI: 3010770794 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    18
    Establishment Types
    3
    Classifications
    16

    Registration Details

    Registration Name
    BioFire Defense, LLC
    Registration Number
    3010770794
    FEI Number
    3010770794
    Status
    Active
    Expiry Year
    2026
    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
    K243822

    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
    Reagents, 2019-Novel Coronavirus Nucleic Acid QJR
    PRD
    Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays PMN
    Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness QMV
    Respiratory Specimen Nucleic Acid Sars-Cov-2 Test QQX
    Reagents, Ebola Zaire Virus (Detected In The West Africa Outbreak In 2014) Nucleic Acid POG
    Instrumentation For Clinical Multiplex Test Systems NSU
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Bordetella Pertussis Dna Assay System OZZ
    Mycoplasma Pneumoniae Dna Assay System OZX
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Chlamydophila Pneumoniae Dna Assay System OZY
    Multiplex Nucleic Acid Detection System For Biothreat Agents QVR

    Proprietary Names

    BioFire COVID-19 Test SARS-COV-2 R-GENE BioFire Warrior Panel Control Kit BioFire Warrior Panel BIOFIRE FILMARRAY Tropical Fever Panel BIOFIRE FILMARRAY TF Panel BIOFIRE FILMARRAY Tropical Fever (TF) Panel BioFire COVID-19 Test 2 BioFire Global Fever Panel BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel FilmArray BioThreat-E Test BIOFIRE SPOTFIRE Module BIOFIRE SPOTFIRE Respiratory (R) Panel BIOFIRE SPOTFIRE Control Station BioFire Global Fever Special Pathogens Panel BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel FilmArray NGDS Warrior Panel FilmArray 2

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device