BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SICKLE CELL

    DI: 00852223007157 · Model: 2243-0 · STERLING DIAGNOSTICS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SICKLE CELL
    Primary DI
    00852223007157
    Version / Model
    2243-0
    Catalog Number
    2243-0
    Company Name
    STERLING DIAGNOSTICS INC
    Labeler DUNS
    155284151
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-14
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    5b3b0f2e-ffd8-4ded-8b07-07eac83c8bb5

    Device Description

    SICKLE CELL (QUALITATIVE Hb-S TEST)

    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

    GMDN Terms

    Code Name
    55906 Haemoglobin S (HbS) IVD, reagent

    Identifiers

    Type ID
    Primary 00852223007157