BEUDAMED
    Product Code: OYM FDA class 3

    Prostrate Cancer Genes Nucleic Acid Amplification Test System

    Unknown

    The Prostate Cancer Genes Nucleic Acid Amplification Test System is an in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes, intended to aid in the diagnosis or management of prostate cancer. It is classified as Class 3 (FDA Class 3), requiring Premarket Approval (PMA) due to the critical implications of the test results on cancer management. The product code is OYM, reviewed under the immunology panel, with no regulation number assigned.

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    510(k)s
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    FEI Numbers
    0
    Registration Numbers
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    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    OYM
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    IM
    Submission Type
    2

    Device Characteristics

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

    Definition

    An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.