BEUDAMED
    Product Code: MKU FDA class 1 21 CFR 862.3220

    Enzyme Immunoassay, Nicotine And Nicotine Metabolites

    Clinical Toxicology

    The Enzyme Immunoassay for Nicotine and Nicotine Metabolites is an in vitro diagnostic test used to detect and measure nicotine and its metabolites, such as cotinine, in biological specimens like urine or blood, primarily used for tobacco use screening, cessation program monitoring, or occupational health assessments. Classified as a Class 1 device under 21 CFR 862.3220 within the Clinical Toxicology specialty, it is subject to general controls only and is generally exempt from 510(k) premarket notification. It carries no implant or life-sustaining flags.

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    510(k)s
    7
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    5
    Years Active
    23

    Basic Information

    Product Code
    MKU
    Device Class
    FDA class 1
    Regulation Number
    862.3220
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    4

    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K192517 Psychemedics Microplate EIA for Cotinine in Hair
    K192299 LZI Cotinine II Enzyme Immunoassay
    K062565 STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
    K021944 COZART EIA COTININE URINE KIT
    K974534 MICRO-PLATE COTININE EIA
    K974234 MICRO-PLATE COTININE EIA
    K972481 AUTO-LYTE COTININE EIA

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.