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

    DYNEX SmartPLEX MMRV IgG Assay Kit

    K Number: K212769 · Decision Sep 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    759

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    Basic Information

    Device Name
    DYNEX SmartPLEX MMRV IgG Assay Kit
    K Number
    K212769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dynex Technologies, Inc.
    Date Received
    August 31, 2021
    Decision Date
    September 29, 2023
    Product Code
    OPL
    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
    OPL Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

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