BEUDAMED
    Product Code: SER FDA class 3 21 CFR 864.1860

    Immunohistochemistry Assay, Antibody, Met

    Hematology

    The MET antibody immunohistochemistry assay is a qualitative immunohistochemical antibody intended to detect MET protein expression in human clinical tissue specimens, functioning as a companion diagnostic to aid in identifying patients eligible for treatment with specific FDA-approved therapeutic drugs targeting the MET pathway. It is classified as FDA Class III (PMA required) under regulation 864.1860 in the Hematology specialty, reviewed by the Pathology panel, with product code SER. Class III classification reflects the high-stakes nature of companion diagnostics; the device is not an implant and does not support life-sustaining functions.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    SER
    Device Class
    FDA class 3
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    2

    Device Characteristics

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

    Definition

    The MET antibody is a qualitative immunohistochemical antibody intended to identify MET protein expression in human clinical tissue specimens. The MET antibody is indicated as an aid in identifying patients eligible for treatment with specific FDA approved therapeutic drugs.

    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.