BEUDAMED
    Product Code: POA FDA not classified

    Reagents, Zika Virus Nucleic Acid

    Unknown

    The Reagents, Zika Virus Nucleic Acid (product code POA) are nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens. The product is currently unclassified (Class N) with no regulation number or formal medical specialty description assigned. The devices are not implants and are not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    POA
    Device Class
    FDA not classified
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    8

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Nucleic acid-based in vitro diagnostic devices for the detection of Zika virus and diagnosis of Zika virus infection in human clinical specimens.

    Unclassified Reason

    11

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.