Home GUDID 00812137010261 CDS-LTX PRIMER
Primary DI 00812137010261
Brand CDS-LTX PRIMER
Company CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model 6 x 16mL
Catalog number 502-007
Device description CDS-LTX Primer is used to prepare the tubing and instrument components on the COULTER HmX/MAXM, STKS and GEN-S instruments prior to analyzing CDS LTX Control.The Coulter HmX/MAXM, STKS and GEN-S instruments require a clean sample line prior to aspirating CDS LTX-Control. Otherwise, performance might be adversely affected through increased coefficients of variation for the volume, conductivity and light scatter parameters.
Published 2016-09-08
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 KRY Calibrator For Platelet Counting
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRY Calibrator For Platelet Counting Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812137010261 Primary GS1 0 00812137011831 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 00812137010261 00812137010261 812137010261 0812137010261 00812137011831 00812137011831 812137011831 0812137011831
GMDN Terms# Term, Definition table Term Definition Reticulocyte count IVD, control A material which is used to verify the performance of an assay that is intended to be used for the qualitative and/or quantitative determination of reticulocyte red blood cells in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 35 Degrees Celsius
Regulatory Flags# DUNS number 048144997 Device count 6 DM exempt 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 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 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 00812137010223 Boule Cal 1 x 3.0mL 501-606 2016-09-06 00812137010230 Boule Con-Diff Tri-Level 9 x 4.5mL 501-607 2016-09-06
Other Devices Sharing Product Codes# 
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