Home GUDID 00812137012173 TIBC Calibrator Set
Primary DI 00812137012173
Brand TIBC Calibrator Set
Company CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model 2 x 2mL
Catalog number 502-157
Device description For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens.
Published 2016-10-13
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 JIT Calibrator, Secondary
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JIT Calibrator, Secondary Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812137012173 Primary GS1 0 00812137012463 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 00812137012173 00812137012173 812137012173 0812137012173 00812137012463 00812137012463 812137012463 0812137012463
GMDN Terms# Term, Definition table Term Definition Total iron binding capacity (TIBC) IVD, calibrator A material which is used to establish known points of reference for an assay intended to be 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 HCT/P 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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