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510(k) Data Aggregation

    K Number
    K182513
    Device Name
    FluChip-8G Influenza A+B Assay
    Manufacturer
    InDevR, Inc.
    Date Cleared
    2019-04-22

    (222 days)

    Product Code
    OZE, NSU, OEP, OQW
    Regulation Number
    866.3980
    Why did this record match?
    Applicant Name (Manufacturer) :

    InDevR, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FluChip-8G Influenza A+B Assay is a multiplex RT-PCR in vitro diagnostic test intended for the qualitative detection and differentiation of seasonal influenza A/H3N2, seasonal influenza A/H1N1pdm09, and "non-seasonal" influenza A subtypes other than seasonal H1N1pdm09 or H3N2. The assay is also intended for the qualitative detection and differentiation of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata. The assay is designed for use on influenza nucleic acids isolated and purified from nasopharyngeal swab and nasal swab specimens from human patients with signs and symptoms of respiratory infection with clinical and epidemiological risk factors.
    Device Description
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