BEUDAMED
    Product Code: DOS FDA class 2 21 CFR 862.3680

    Thin Layer Chromatography, Primidone

    Clinical Toxicology

    The Thin Layer Chromatography system for Primidone is a laboratory analytical device used to detect and identify primidone, an anticonvulsant drug, in patient specimens through thin-layer chromatographic separation for therapeutic drug monitoring or toxicological screening. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DOS, 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
    DOS
    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