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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Accutest NicAlert Saliva Cotinine Test

    DI: 10763924043580 · Model: DS43 · JANT PHARMACAL CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

    Basic Information

    Brand Name
    Accutest NicAlert Saliva Cotinine Test
    Primary DI
    10763924043580
    Version / Model
    DS43
    Company Name
    JANT PHARMACAL CORPORATION
    Labeler DUNS
    797393659
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    44513f8b-ed86-4402-8cab-2772659152c4

    Device Description

    Semi quantitative test for the detection of Cotinine (Nicotine Metabolite) in a Saliva specimen

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MRS Test System, Nicotine, Cotinine, Metabolites

    GMDN Terms

    Code Name
    55579 Cotinine (nicotine metabolite) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 10763924043580
    Unit of Use 00763924043583

    Premarket Submissions

    Submission Number Supplement Number
    K021688 000