BEUDAMED
    Product Code: LDB FDA class 2 21 CFR 862.3645

    U.V. Spectrometry, Carbamazepine

    Clinical Toxicology

    UV spectrometry for carbamazepine measurement is a laboratory technique using ultraviolet spectrophotometry to quantify carbamazepine levels in patient specimens, supporting therapeutic drug monitoring for patients with epilepsy or bipolar disorder where maintaining appropriate serum levels is clinically important. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is LDB, regulated under 21 CFR 862.3645, in the Clinical Toxicology specialty. Third-party review eligibility applies.

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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
    LDB
    Device Class
    FDA class 2
    Regulation Number
    862.3645
    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