BEUDAMED
    Product Code: LPJ FDA class 3 21 CFR 864.1860

    Kit, Assay, Estrogen Receptor

    Hematology

    The Estrogen Receptor Assay Kit is an in vitro diagnostic device used to detect and quantify estrogen receptor levels in tissue specimens, most commonly breast cancer tissue, to help determine eligibility for hormone therapy. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) due to the critical role accurate receptor quantification plays in oncology treatment decisions. The product code is LPJ, regulated under 21 CFR 864.1860, within the Hematology medical specialty. No special flags apply to this device.

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

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

    Device Characteristics

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