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

    GeneSTAT.MDx Coccidioides Assay

    K Number: DEN170041 · Decision Nov 29, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    120

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    Basic Information

    Device Name
    GeneSTAT.MDx Coccidioides Assay
    K Number
    DEN170041
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3376
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    Dxna, LLC
    Date Received
    August 1, 2017
    Decision Date
    November 29, 2017
    Product Code
    QAA
    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
    QAA Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens