BEUDAMED
    Product Code: JIK FDA class 1 21 CFR 862.1640

    Dry Ash Method, Protein-Bound Iodine

    Clinical Chemistry

    Dry Ash Method for Protein-Bound Iodine is a clinical chemistry test system using dry ashing incineration to digest serum proteins, followed by iodine quantification, providing a measure of protein-bound iodine as an indirect indicator of thyroid hormone status. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is JIK, regulated under 21 CFR 862.1640, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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    Basic Information

    Product Code
    JIK
    Device Class
    FDA class 1
    Regulation Number
    862.1640
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

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