Home GUDID 00812137012104 Direct TIBC Reagent Set
Primary DI 00812137012104
Brand Direct TIBC Reagent Set
Company CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model R1 x 90mL, R2 x 60mL
Catalog number 501-444
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.
Published 2016-10-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name JIY Photometric Method, Iron (Non-Heme)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JIY Photometric Method, Iron (Non-Heme) Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812137012104 Primary GS1 0 00812137012371 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00812137012104 00812137012104 812137012104 0812137012104 00812137012371 00812137012371 812137012371 0812137012371
GMDN Terms# Term, Definition table Term Definition Total iron binding capacity IVD (TIBC), reagent 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 048144997 Device count 2 DM exempt true Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00812137011879 AMYLASE (CNPG3) Reagent Set 4 x 120 mL 501-400 2016-10-12 00812137011848 Albumin Reagent 500 mL 501-397 2016-10-12 00812137012005 LDH Reagent Set R1 x 500mL, R2 x 125mL 501-413 2016-10-12 00812137011855 Alkaline Phosphatase Reagent Set R1 x 500 mL, R2 x 125 mL 501-398 2016-10-12 00812137011886 AST (SGOT) Reagent Set R1 x 500mL, R2 x 125mL 501-401 2016-10-12 00812137011961 Creatinine Reagent Set R1 x 500mL, R2 x 125mL 501-409 2016-10-12 00812137012098 CRP Reagent Set R1 x 50mL, R2 x 50mL 501-435 2016-10-12 00812137012142 CRP Calibrator Set 5 x 2mL 502-154 2016-10-12 00812137012159 CRP Control Set L1 x 3 x 3mL, L2 x 3 x 3mL 502-155 2016-10-12 00812137012197 Multi-Analyte Lipid Control Set L1 x 3mL, L2 x 3mL, L3 x 3mL 502-160 2016-10-12 00812137012111 Chemistry Calibrator Set 10 x 5mL, 1 x 50mL 502-151 2016-10-12 00812137012128 Chemistry Control Level I Set 10 x 5mL 502-152 2016-10-12 00812137012135 Chemistry Control Level II Set 10 x 5mL 502-153 2016-10-12 00001812701208 Triglycerides Reagent 500mL 501-417 2016-10-12 00812137010254 CDS-LTX CONTROL 6 x 16 mL 502-006 2016-09-08 00812137010261 CDS-LTX PRIMER 6 x 16mL 502-007 2016-09-08 00812137011947 Carbon Dioxide Reagent 120mL 501-407 2016-10-12 00812137011916 Urea Nitrogen Reagent Set R1 x 500mL, R2 x 125mL 501-404 2016-10-12 00081213701184 Albumin Reagent 500 mL 501-397 2016-10-12 00812137010216 Boule Con-Diff Tri-Level 6 x 4.5mL 501-605 2016-09-02
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