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.

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

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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