BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Direct TIBC Reagent Set

    DI: 00812137012104 · Model: R1 x 90mL, R2 x 60mL · CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    2

    Basic Information

    Brand Name
    Direct TIBC Reagent Set
    Primary DI
    00812137012104
    Version / Model
    R1 x 90mL, R2 x 60mL
    Catalog Number
    501-444
    Company Name
    CLINICAL DIAGNOSTIC SOLUTIONS, INC.
    Labeler DUNS
    048144997
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    2
    Record Status
    Published
    Publish Date
    2016-10-12
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    130b8f43-222c-4553-b59d-27087ebe268e

    Device Description

    For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Total iron-binding capacity (TIBC) is the measure of the ability of serum proteins, principally transferrin, to bind iron. It is the maximum concentration of iron that the serum proteins can bind. Together with the total serum iron concentration, the TIBC is used in the diagnosis and treatment of iron deficiency anemia, other disorders of iron metabolism, and chronic inflammatory disorders. As an index of nutritional status, Serum TIBC is increased in iron deficiency, and decreased in anemia that is due to chronic disease.

    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
    Yes
    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
    JIY Photometric Method, Iron (Non-Heme)

    GMDN Terms

    Code Name
    53908 Total iron binding capacity IVD (TIBC), reagent

    Identifiers

    Type ID
    Primary 00812137012104
    Unit of Use 00812137012371

    Customer Contacts

    Phone
    8004533328
    Email
    [email protected]

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius