BEUDAMED
    Product Code: JQL FDA class 1 21 CFR 862.1790

    Spectrophotometric, Uroporphyrin

    Clinical Chemistry

    The Spectrophotometric, Uroporphyrin test is a clinical chemistry diagnostic device that uses spectrophotometric measurement to detect and quantify uroporphyrin in biological specimens such as urine or blood, supporting the diagnosis of porphyrias and other disorders of heme biosynthesis characterized by elevated uroporphyrin excretion. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JQL and is regulated under 21 CFR 862.1790, within the Clinical Chemistry medical specialty.

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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
    JQL
    Device Class
    FDA class 1
    Regulation Number
    862.1790
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

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

    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.