BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TOTAL BILIRUBIN

    DI: 00852223007232 · Model: 2135-0 · STERLING DIAGNOSTICS INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    TOTAL BILIRUBIN
    Primary DI
    00852223007232
    Version / Model
    2135-0
    Catalog Number
    2135-0
    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
    91b3af27-c122-4960-b647-27f390fb0592

    Device Description

    TOTAL BILIRUBIN (MODIFIED MALLOY-EVELYN)

    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
    53231 Total bilirubin IVD, reagent

    Identifiers

    Type ID
    Primary 00852223007232