BEUDAMED
    Product Code: NXG FDA class 3

    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

    Unknown

    The Fluorescence In Situ Hybridization, Topoisomerase II Alpha (TOP2A), Gene Amplification and Deletion kit (product code NXG) is a FISH-based diagnostic kit used to detect TOP2A gene copy number changes, including amplification and deletion, in formalin-fixed, paraffin-embedded human breast cancer tissue specimens, supporting oncology decision-making. It is classified as FDA Class 3, requiring Premarket Approval (PMA), and is reviewed by the Pathology panel. The device carries no implant or life-sustaining flags.

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

    Product Code
    NXG
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    PA
    Submission Type
    2

    Device Characteristics

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

    Definition

    Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.