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

    FilmArray Global Fever Panel

    K Number: DEN200043 · Decision Nov 20, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    147

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    Basic Information

    Device Name
    FilmArray Global Fever Panel
    K Number
    DEN200043
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3966
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Biofire Defense, LLC
    Date Received
    June 26, 2020
    Decision Date
    November 20, 2020
    Product Code
    QMV
    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
    QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

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    BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

    FDA 510(k)
    FDA Class 2 ·Microbiology
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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
    K211079 BioFire COVID-19 Test 2
    K202382 FilmArray Global Fever Panel External Control Kit
    K170883 FilmArray NGDS Warrior Panel
    DEN160048 FilmArray NGDS Warrior Panel