BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DC-TROL LEVELS 1 & 2

    DI: 00628063401222 · Model: SM-057 · SEKISUI DIAGNOSTICS, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DC-TROL LEVELS 1 & 2
    Primary DI
    00628063401222
    Version / Model
    SM-057
    Company Name
    SEKISUI DIAGNOSTICS, LLC
    Labeler DUNS
    966812344
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-30
    Public Version
    2
    Public Version Date
    2020-12-21
    Public Version Status
    Update
    Public Device Record Key
    8e819724-7edb-4cde-b9ec-454c57a640e4

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    47869 Multiple-type clinical chemistry analyte profile IVD, control

    Identifiers

    Type ID
    Primary 00628063401222