BEUDAMED
    Product Code: DNX FDA class 2 21 CFR 862.3550

    Lead, Protoporphyrin Zinc Method, Fluorometric

    Clinical Toxicology

    The Lead Protoporphyrin Zinc Method Fluorometric test is a clinical laboratory device that uses fluorometric measurement of zinc protoporphyrin levels in blood as an indicator of lead exposure, providing a screen for lead poisoning. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DNX, regulated under 21 CFR 862.3550, within the Clinical Toxicology specialty. No special regulatory flags apply.

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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
    DNX
    Device Class
    FDA class 2
    Regulation Number
    862.3550
    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