BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Total Bilirubin LiquiColor®

    DI: 00657498000588 · Model: 0230-450 · STANBIO LABORATORY, L.P.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Total Bilirubin LiquiColor®
    Primary DI
    00657498000588
    Version / Model
    0230-450
    Catalog Number
    0230-450
    Company Name
    STANBIO LABORATORY, L.P.
    Labeler DUNS
    045361136
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    2f5a51e7-c623-4bda-97d8-4eac9d1fe18c

    Device Description

    The Stanbio Total Bilirubin LiquiColor® test system is a device intended to measure the levels of bilirubin (total) in serum and plasma. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    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
    JFM Enzymatic Method, Bilirubin

    GMDN Terms

    Code Name
    53230 Total bilirubin IVD, kit, enzyme spectrophotometry

    Identifiers

    Type ID
    Primary 00657498000588

    Customer Contacts

    Phone
    18005315535
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius