BEUDAMED
    Product Code: JND FDA class 1 21 CFR 862.1565

    Nadp Reduction, 6-Phosphogluconate Dehydrogenase

    Clinical Chemistry

    This device is a clinical chemistry reagent system using NADP reduction to measure 6-phosphogluconate dehydrogenase activity in patient specimens, an enzyme in the pentose phosphate pathway relevant to the evaluation of red blood cell enzyme defects and related hemolytic conditions. It is classified as FDA Class 1, the lowest risk category, requiring only general controls with no premarket notification. The product code is JND, regulated under 21 CFR 862.1565, 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
    JND
    Device Class
    FDA class 1
    Regulation Number
    862.1565
    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.