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

    QUIDEL MOLECULAR INFLUENZA A + B ASSAY

    K Number: K131728 · Decision Aug 29, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    19
    Applicant Total
    93
    Review Days
    78

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    Basic Information

    Device Name
    QUIDEL MOLECULAR INFLUENZA A + B ASSAY
    K Number
    K131728
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Quidel Corp.
    Date Received
    June 12, 2013
    Decision Date
    August 29, 2013
    Product Code
    OZE
    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
    OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

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    Other Clearances by Quidel Corp.

    K Number Device Name
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    K122189 QUIDEL MOLECULAR RSV + HMPV ASSAY
    K123998 QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY
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