BEUDAMED
    FDA 510(k) Unknown 🇺🇸 United States

    FilmArray NGDS Warrior Panel

    K Number: DEN160048 · Decision Feb 14, 2017
    View on FDA
    Classifications
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    120

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    Basic Information

    Device Name
    FilmArray NGDS Warrior Panel
    K Number
    DEN160048
    Clearance Type
    Direct
    Decision
    Unknown
    Applicant
    Biofire Defense, LLC
    Date Received
    October 17, 2016
    Decision Date
    February 14, 2017
    Product Code
    PRD
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    Third Party
    N

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    FDA 510(k)

    Other Clearances by Biofire Defense, LLC

    K Number Device Name
    K243822 BioFire Warrior Panel; BioFire Warrior Panel Control Kit
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    K220870 BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel
    K221460 BioFire COVID-19 Test 2
    K211079 BioFire COVID-19 Test 2
    K202382 FilmArray Global Fever Panel External Control Kit
    DEN200043 FilmArray Global Fever Panel
    K170883 FilmArray NGDS Warrior Panel