BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sickle-Heme

    DI: 00860003629901 · Model: GLD-100 · GREAT LAKES DIAGNOSTICS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Sickle-Heme
    Primary DI
    00860003629901
    Version / Model
    GLD-100
    Company Name
    GREAT LAKES DIAGNOSTICS, INC.
    Labeler DUNS
    804870996
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-12-13
    Public Version
    1
    Public Version Date
    2021-12-22
    Public Version Status
    New
    Public Device Record Key
    db824c8d-c88b-47ab-99e0-6798e4c295d3

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    GHM Test, Sickle Cell

    GMDN Terms

    Code Name
    55906 Haemoglobin S (HbS) IVD, reagent

    Identifiers

    Type ID
    Primary 00860003629901