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

    ZIKV Detect 2.0 IgM Capture ELISA

    K Number: DEN180069 · Decision May 23, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    148

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    Basic Information

    Device Name
    ZIKV Detect 2.0 IgM Capture ELISA
    K Number
    DEN180069
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    866.3935
    Medical Specialty
    Microbiology
    Decision
    Unknown
    Applicant
    InBios International, Inc.
    Date Received
    December 26, 2018
    Decision Date
    May 23, 2019
    Product Code
    QFO
    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
    QFO Zika Virus Serological Reagents

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