BEUDAMED
    Product Code: NGG FDA class 2 21 CFR 862.3610

    Test, Methamphetamine, Over The Counter

    Clinical Toxicology

    The Test, Methamphetamine, Over The Counter (product code NGG) is an in vitro diagnostic test designed for consumer use to detect methamphetamine and its metabolites in urine specimens, enabling home-based drug screening. It is classified as an FDA Class 2 device within the Clinical Toxicology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    NGG
    Device Class
    FDA class 2
    Regulation Number
    862.3610
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K182654 SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card

    FEI Numbers

    This FDA classification entry is associated with 49 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 49 registration numbers. Click on an entry to view related FDA registrations.