BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DRI Cotinine Assay

    DI: 00884883012905 · Model: 10018516 · Microgenics Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DRI Cotinine Assay
    Primary DI
    00884883012905
    Version / Model
    10018516
    Company Name
    Microgenics Corporation
    Labeler DUNS
    122153799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-12
    Public Version
    4
    Public Version Date
    2019-07-09
    Public Version Status
    Update
    Public Device Record Key
    54ae2ec4-0ca6-48b9-b66d-33dd04ecfeee

    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
    Yes
    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
    MKU Enzyme Immunoassasy, Nocotine And Nicotine Metabolites

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00884883012905