BEUDAMED
    Product Code: JFQ FDA class 2 21 CFR 866.5210

    P-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin

    Immunology

    P-Phenylenediamine/EDTA (Spectrophotometric) for Ceruloplasmin is an immunology test system that uses a spectrophotometric oxidase reaction to measure ceruloplasmin, a copper-carrying protein in blood, for use in diagnosing Wilson's disease and other copper metabolism disorders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and general and special controls compliance. The product code is JFQ, regulated under 21 CFR 866.5210, within the Immunology 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
    JFQ
    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