BEUDAMED
    Product Code: CJB FDA class 2 21 CFR 862.1045

    Chromatographic Separation/Radioimmunoassay, Aldosterone

    Clinical Chemistry

    The Chromatographic Separation/Radioimmunoassay, Aldosterone test system (product code CJB) is an in-vitro diagnostic device used in clinical chemistry to measure aldosterone levels in plasma or urine using a combination of chromatographic separation and radioimmunoassay, supporting the diagnosis of primary aldosteronism, Conn's syndrome, and other disorders of mineralocorticoid regulation. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1045 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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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
    CJB
    Device Class
    FDA class 2
    Regulation Number
    862.1045
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    1

    Device Characteristics

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