BEUDAMED
    Product Code: MGV FDA class 2 21 CFR 862.1235

    Radioimmunoassay For Cyclosporine

    Clinical Chemistry

    The radioimmunoassay (RIA) for cyclosporine is a clinical chemistry in vitro diagnostic device that uses radiolabeled immunoassay technology to quantitatively measure cyclosporine drug levels in patient specimens, supporting therapeutic drug monitoring for immunosuppressed patients. It is classified as FDA Class II under 21 CFR 862.1235 within the Clinical Chemistry specialty, requiring 510(k) premarket clearance. The product code is MGV and the device is not implanted. Full GMP compliance is required.

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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
    MGV
    Device Class
    FDA class 2
    Regulation Number
    862.1235
    Medical Specialty
    Clinical Chemistry
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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