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

    CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,

    K Number: K181736 · Decision Jul 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    28

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    Basic Information

    Device Name
    CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
    K Number
    K181736
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3980
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Centers For Disease Control and Prevention (CDC)
    Date Received
    July 2, 2018
    Decision Date
    July 30, 2018
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OZE), ordered by most recent decision date.

    CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

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    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)

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    ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2

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    CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

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    Other Clearances by Centers For Disease Control and Prevention (CDC)

    K Number Device Name
    K170940 Rickettsia Real-time PCR Assay
    DEN160016 Variola virus Real-Time PCR Assay
    K161556 CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit
    K153148 CDC Human Influenza Virus Real- time RT-PCR Diagnostic Panel, Influenza A/H5 Subtyping
    K140426 ANTHRACIS REAL-TIME PCR ASSAY