BEUDAMED
    Product Code: DJX FDA class 2 21 CFR 862.3380

    Radioimmunoassay, Ethosuximide

    Clinical Toxicology

    The Radioimmunoassay for Ethosuximide is a quantitative laboratory test employing radiolabeled reagents and antibody-based methodology to measure ethosuximide, an antiepileptic drug used to treat absence seizures, in patient blood specimens for therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3380 within the Clinical Toxicology specialty. The device qualifies for third-party 510(k) review.

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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
    DJX
    Device Class
    FDA class 2
    Regulation Number
    862.3380
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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