BEUDAMED
    Product Code: LAH FDA class 2 21 CFR 862.3650

    High Pressure Liquid Chromatography, Opiates

    Clinical Toxicology

    High pressure liquid chromatography for opiate analysis is a laboratory technique used in clinical toxicology to separate, identify, and quantify opiates in patient specimens for therapeutic monitoring or toxicological investigation. It is an FDA Class 2 device, requiring 510(k) premarket notification. The product code is LAH, regulated under 21 CFR 862.3650, in the Clinical Toxicology specialty. Third-party review is available.

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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
    LAH
    Device Class
    FDA class 2
    Regulation Number
    862.3650
    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