BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CEDIA Cannabinoids OFT Assay

    DI: 00884883000216 · Model: 10018585 · Microgenics Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    CEDIA Cannabinoids OFT Assay
    Primary DI
    00884883000216
    Version / Model
    10018585
    Company Name
    Microgenics Corporation
    Labeler DUNS
    122153799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    5
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    c86b3531-5737-4c7e-a3b8-60023a1d6872

    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
    LDJ Enzyme Immunoassay, Cannabinoids

    GMDN Terms

    Code Name
    55550 Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00884883000216

    Premarket Submissions

    Submission Number Supplement Number
    K101744 000