BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BioFire Diagnostics, LLC

    Reg #: 3002773840 · FEI: 3002773840 · Expires 2026
    View on FDA
    Products
    22
    Proprietary Names
    56
    Establishment Types
    4
    Classifications
    22

    Registration Details

    Registration Name
    BioFire Diagnostics, LLC
    Registration Number
    3002773840
    FEI Number
    3002773840
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    515 Colorow Drive
    City
    Salt Lake City
    State
    UT
    ZIP
    84108
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN200031

    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
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Instrumentation For Clinical Multiplex Test Systems NSU
    Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System PCH
    Fungal Organisms, Nucleic Acid-Based Assay PEO
    Gram-Negative Bacteria And Associated Resistance Markers PEN
    Gram-Positive Bacteria And Their Resistance Markers PAM
    Parainfluenza Multiplex Nucleic Acid Assay OOU
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Mycoplasma Pneumoniae Dna Assay System OZX
    Human Metapneumovirus (Hmpv) Rna Assay System OEM
    Influenza A Virus Subtype Differentiation Nucleic Acid Assay OEP
    Bordetella Pertussis Dna Assay System OZZ
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System PLO
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE
    Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System PGX
    Chlamydophila Pneumoniae Dna Assay System OZY
    Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System QDS
    Respiratory Panel QDP
    Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness QMV
    Real Time Nucleic Acid Amplification System OOI
    Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System QSN

    Proprietary Names

    BioFire Respiratory Panel 2.1 BioFire RP2.1 FilmArray 2 FilmArray® Gastrointestinal (GI) Panel BIOFIRE FILMARRAY BCID2 Panel BIOFIRE BCID2 Panel BIOFIRE Blood Culture Identification 2 Panel FilmArray Respiratory Panel (RP) For Use With FilmArray Torch FilmArray ME Panel for use on FilmArray Torch BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini BIOFIRE SPOTFIRE R/ST Panel Mini BioFire BCID2 Panel BioFire Blood Culture Identification 2 Panel BioFire Blood Culture Identification 2 (BCID2) Panel FILMARRAY GI Panel BIOFIRE GI Panel BIOFIRE FILMARRAY GI Panel BIOFIRE FILMARRAY Gastrointestinal Panel BIOFIRE FILMARRAY Gastrointestinal (GI) Panel FilmArray Gastrointestinal (GI) Panel BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel BIOFIRE SPOTFIRE R/ST Panel FilmArray GI Panel for use with FilmArray Torch BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid BIOFIRE FILMARRAY GI Panel Mid BIOFIRE SPOTFIRE Module BIOFIRE SPOTFIRE Respiratory (R) Panel BIOFIRE SPOTFIRE Control Station BioFire Pneumo plus Panel BioFire Pneumonia Plus Panel BioFire FilmArray Pneumonia plus Panel BIOFIRE SPOTFIRE R Panel Mini BIOFIRE SPOTFIRE Respiratory (R) Panel Mini BIOFIRE FILMARRAY Pneumonia Panel plus SPOTFIRE R/ST Panel Mini BIOFIRE FILMARRAY Gastroinestinal (GI) Panel BioFire Pneumonia Panel BioFire Pneumo Panel BioFire FilmArray Pneumonia Panel BIOFIRE FILMARRAY Tropical Fever Panel BIOFIRE FILMARRAY TF Panel BIOFIRE FILMARRAY Tropical Fever (TF) Panel BIOFIRE Pneumonia Panel BIOFIRE FILMARRAY Pneumonia Panel BIOFIRE Pneumonia Panel plus FilmArray Meningitis/Encephalitis (ME) Panel BioFire JI Panel BioFire Joint Infection Panel BioFire Joint Infection (JI) Panel BIOFIRE RP2.1 Panel plus BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) plus Panel Mini BIOFIRE SPOTFIRE R/ST plus Panel BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) BIOFIRE RP2.1plus Panel BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) plus Panel BIOFIRE SPOTFIRE R/ST plus Panel Mini

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only