BEUDAMED
    Product Code: DLD FDA class 2 21 CFR 862.3270

    Thin Layer Chromatography, Codeine

    Clinical Toxicology

    The Thin Layer Chromatography system for Codeine is a laboratory analytical device used to detect and identify codeine in biological specimens through chromatographic separation on a thin-layer medium. It is a Class 2 device requiring a 510(k) premarket notification before marketing. The product code is DLD, regulated under 21 CFR 862.3270, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    DLD
    Device Class
    FDA class 2
    Regulation Number
    862.3270
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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