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

    CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT

    K Number: K133869 · Decision Jan 17, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    28

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    Basic Information

    Device Name
    CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, INFLUENZA A/B TYPING KIT
    K Number
    K133869
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Center For Disease Control and Prevention (Cdc)
    Date Received
    December 20, 2013
    Decision Date
    January 17, 2014
    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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