BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIOFIRE SPOTFIRE R Panel Mini

    Reg #: 3002773840 · FEI: 3002773840 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    4

    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
    K230719

    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
    Non-Sars Coronavirus Multiplex Nucleic Acid Assay OTG
    Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents QOF
    Respiratory Virus Panel Nucleic Acid Assay System OCC
    Influenza A And Influenza B Multiplex Nucleic Acid Assay OZE

    Proprietary Names

    BIOFIRE SPOTFIRE R Panel Mini BIOFIRE SPOTFIRE Respiratory (R) Panel Mini

    Establishment Types

    Manufacture Medical Device