BEUDAMED
    Product Code: MAR FDA class 2 21 CFR 862.1235

    Cyclosporine And Metabolites Serum Assay

    Clinical Chemistry

    The cyclosporine and metabolites serum assay is a clinical chemistry device used to quantitatively measure cyclosporine drug levels and its metabolites in patient serum or blood, enabling therapeutic drug monitoring for transplant recipients and patients on immunosuppressive therapy. 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 MAR and the device is not implanted. Full GMP compliance is required.

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    510(k)s
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    FEI Numbers
    0
    Registration Numbers
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    Unique Applicants
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    Years Active
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    Basic Information

    Product Code
    MAR
    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