BEUDAMED
    Product Code: NFW FDA class 2 21 CFR 862.3870

    Test, Cannabinoid, Over The Counter

    Clinical Toxicology

    The Test, Cannabinoid, Over The Counter (product code NFW) is an in vitro diagnostic test designed for consumer home use to detect cannabinoids, primarily THC metabolites, in urine specimens for drug screening purposes. 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
    4
    FEI Numbers
    49
    Registration Numbers
    49
    Unique Applicants
    4
    Years Active
    6

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    Basic Information

    Product Code
    NFW
    Device Class
    FDA class 2
    Regulation Number
    862.3870
    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 4 510(k) clearances via K numbers.

    K Number Device Name
    K252523 Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test
    K231978 BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50
    K192301 BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
    K191924 SAFECARE® THC Urine Strip Test

    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.