BEUDAMED
    Product Code: QYD FDA class 2 21 CFR 862.3115

    Adalimumab Assay

    Clinical Toxicology

    The adalimumab assay (product code QYD) is a Class 2 Clinical Toxicology in vitro diagnostic device (regulation 862.3115) intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody, to support therapeutic drug monitoring. It requires 510(k) clearance. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    QYD
    Device Class
    FDA class 2
    Regulation Number
    862.3115
    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 device intended for the measurement of adalimumab, an anti-tumor necrosis factor alpha monoclonal antibody

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    DEN220023 Procise ADL

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.