BEUDAMED
    Product Code: DPQ FDA class 2 21 CFR 862.3680

    Liquid Chromatography, Primidone

    Clinical Toxicology

    The Liquid Chromatography system for Primidone is a laboratory analytical device that uses liquid chromatographic separation to detect and quantify primidone and its metabolites in patient serum or plasma for therapeutic drug monitoring of this anticonvulsant medication. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DPQ, regulated under 21 CFR 862.3680, within the Clinical Toxicology specialty. It is eligible 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
    DPQ
    Device Class
    FDA class 2
    Regulation Number
    862.3680
    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