BEUDAMED
    Product Code: DCT FDA class 2 21 CFR 866.5210

    Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control

    Immunology

    This is an immunological reagent kit for detecting and measuring ceruloplasmin, the copper-containing plasma oxidase responsible for ferroxidase activity and copper transport, using rhodamine as a fluorescent conjugate. The kit includes antigen, antiserum, and control components for clinical laboratory immunoassays used in evaluating copper metabolism disorders such as Wilson's disease. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DCT, regulated under 21 CFR 866.5210, within the Immunology specialty.

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    510(k)s
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    FEI Numbers
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    Registration Numbers
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    Basic Information

    Product Code
    DCT
    Device Class
    FDA class 2
    Regulation Number
    866.5210
    Medical Specialty
    Immunology
    Review Panel
    IM
    Submission Type
    4

    Device Characteristics

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