BEUDAMED
    Product Code: LAB FDA class 2 21 CFR 862.3170

    Thin Layer Chromatography, Benzodiazepine

    Clinical Toxicology

    Thin layer chromatography for benzodiazepine testing is a separation-based analytical technique used in clinical toxicology to screen for or confirm the presence of benzodiazepines in patient samples. It falls under FDA Class 2, which requires 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is LAB, regulated under 21 CFR 862.3170, 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
    LAB
    Device Class
    FDA class 2
    Regulation Number
    862.3170
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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