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    FDA UDI In Commercial Distribution 🇺🇸 United States

    CEDIA Multi-Drug OFT Negative Calibrator

    DI: 00884883011045 · Model: 10014954 · Microgenics Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CEDIA Multi-Drug OFT Negative Calibrator
    Primary DI
    00884883011045
    Version / Model
    10014954
    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
    2019-07-04
    Public Version Status
    Update
    Public Device Record Key
    ccb34415-f881-42f9-8f77-6c2024312a20

    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
    DKB Calibrators, Drug Mixture

    GMDN Terms

    Code Name
    55460 Multiple drugs of abuse IVD, calibrator

    Identifiers

    Type ID
    Primary 00884883011045