BEUDAMED
    Product Code: OAV FDA class 2 21 CFR 862.3840

    Mycophenolic Acid Test System

    Clinical Toxicology

    The Mycophenolic Acid Test System (product code OAV) is an in vitro diagnostic reagent system intended for the quantitative determination of total mycophenolic acid in human serum or plasma, used as an aid in therapeutic drug monitoring for renal and cardiac transplant patients receiving mycophenolic acid therapy. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 862.3840 within the Clinical Toxicology specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    3
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    3
    Years Active
    5

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    Basic Information

    Product Code
    OAV
    Device Class
    FDA class 2
    Regulation Number
    862.3840
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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

    Definition

    An in vitro diagnostic reagent system intended for use in the quantitative determination of total mycophenolic acid in human serum or plasma as an aid in the management of mycophenolic acid therapy in renal and cardiac transplant patients.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K102772 DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)
    K081083 CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS
    K063520 ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.