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

    BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel

    K Number: K213362 · Decision Mar 22, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    526

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    Basic Information

    Device Name
    BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel
    K Number
    K213362
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.4000
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Defense, LLC
    Date Received
    October 12, 2021
    Decision Date
    March 22, 2023
    Product Code
    QVR
    Advisory Committee
    Immunology
    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
    QVR Multiplex Nucleic Acid Detection System For Biothreat Agents

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    K202382 FilmArray Global Fever Panel External Control Kit
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    K170883 FilmArray NGDS Warrior Panel
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