BEUDAMED
    Product Code: DOM FDA class 2 21 CFR 862.3250

    Thin Layer Chromatography, Benzoylecgnonine

    Clinical Toxicology

    The Thin Layer Chromatography system for Benzoylecgnonine is a laboratory analytical device used to separate and identify benzoylecgnonine, the primary cocaine metabolite, in patient urine or other biological specimens using thin-layer chromatographic techniques. It is a Class 2 device requiring 510(k) premarket clearance. The product code is DOM, regulated under 21 CFR 862.3250, 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
    DOM
    Device Class
    FDA class 2
    Regulation Number
    862.3250
    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