BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BioFire COVID-19 Test 2

    K Number: K211079 · Decision Nov 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    203

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    Basic Information

    Device Name
    BioFire COVID-19 Test 2
    K Number
    K211079
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3981
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Defense, LLC
    Date Received
    April 12, 2021
    Decision Date
    November 1, 2021
    Product Code
    QQX
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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    Other Clearances by Biofire Defense, LLC

    K Number Device Name
    K243822 BioFire Warrior Panel; BioFire Warrior Panel Control Kit
    K213362 BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
    K220870 BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
    K221460 BioFire COVID-19 Test 2
    K202382 FilmArray Global Fever Panel External Control Kit
    DEN200043 FilmArray Global Fever Panel
    K170883 FilmArray NGDS Warrior Panel
    DEN160048 FilmArray NGDS Warrior Panel