Devices & Diagnostics > Device

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.


by CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Product Overview

For use in the determination of total iron
Direct TIBC Reagent Set - R1 x 90mL, R2 x 60mL


Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total iron binding capacity (TIBC) of a clinical specimen.


Environmental Conditions

  • Storage Environment Temperature - Degrees Celsius
    • 8.00
    • 2.00


    • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: JIY

    Device Name: Photometric Method, Iron (Non-Heme)

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: CH

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 862.1410

    Third Party Flag: N

    Medical Specialty: CH


    Device Identifiers

    Device Id: 00812137012104

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


    Device Id: 00812137012371

    Device Type: Unit of Use

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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