BEUDAMED
    Product Code: LPX FDA class 2 21 CFR 862.3645

    Radioceptor Assay, Neuroleptic Drugs

    Clinical Toxicology

    The Neuroleptic Drug Radioceptor Assay is an in vitro diagnostic device that uses a radioligand receptor binding technique to measure the effective concentration of neuroleptic (antipsychotic) drugs in biological specimens, assisting in therapeutic drug monitoring. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LPX, regulated under 21 CFR 862.3645, within the Clinical Toxicology medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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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
    LPX
    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