BEUDAMED
    Product Code: OYB FDA class 3

    Kit, Rna Detection, Human Papillomavirus

    Unknown

    The Kit, RNA Detection, Human Papillomavirus is an in vitro diagnostic device used for the detection of human papillomavirus (HPV) RNA to aid in assessing the risk of cancer, particularly cervical cancer. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) because of its critical role in cancer risk stratification. The product code is OYB, reviewed under the microbiology panel, with no regulation number assigned.

    View on FDA
    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    OYB
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    MI
    Submission Type
    2

    Device Characteristics

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

    Definition

    For the detection of human papillomavirus RNA to aid in assessing risk of cancer.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.