BEUDAMED
    Product Code: JNG FDA class 1 21 CFR 862.1615

    Radioimmunoassay, Pregnenolone

    Clinical Chemistry

    The Radioimmunoassay, Pregnenolone test is a clinical laboratory diagnostic device used to measure pregnenolone, a steroid precursor hormone, in biological samples such as serum or plasma. Pregnenolone measurements assist in evaluating adrenal and gonadal steroidogenesis and are relevant in the diagnosis of certain endocrine disorders. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JNG and is regulated under 21 CFR 862.1615, within the Clinical Chemistry medical specialty.

    View on FDA
    510(k)s
    0
    FEI Numbers
    9
    Registration Numbers
    9
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    JNG
    Device Class
    FDA class 1
    Regulation Number
    862.1615
    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 9 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.