Home GUDID 00812137010254 CDS-LTX CONTROL
Primary DI 00812137010254
Brand CDS-LTX CONTROL
Company CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Model 6 x 16 mL
Catalog number 502-006
Device description CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S instruments. Prepare instrument with CDS LTX Primer immediately prior to CDS-LTX Control measurements.Accurate differential and reticulocyte measurements on COULTER HmX/MAXM, STKS and GEN-S instruments are assured by demonstrating consistent performance of volume, conductivity and light scatter parameters, using a particle of uniform size with appropriate light scattering characteristics. CDS-LTX Control validates the stability of the electrical processing and fluidic flow rate systems used to measure volume, conductivity and light scatter.
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 KRX Calibrator For Cell Indices
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KRX Calibrator For Cell Indices Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00812137010254 Primary GS1 0 00812137011824 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 00812137010254 00812137010254 812137010254 0812137010254 00812137011824 00812137011824 812137011824 0812137011824
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 2 Degrees Celsius 10 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 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 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# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00815762023446 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2025-12-01 00815762023453 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2025-12-01 06936415992927 SC-CAL PLUS Shenzhen Mindray Bio-Medical Electronics Co., Ltd. KRX 2025-01-17 00380740151294 Alinity Abbott GmbH KRX 2023-11-16 14987562460332 XN CAL SYSMEX CORPORATION KRX 2017-10-06 14987562460356 XN CAL PF SYSMEX CORPORATION KRX 2017-10-06 14987562460592 X-CAL Calibrator SYSMEX CORPORATION KRX 2017-10-06 D757U2260K1 One Step Plus KIT BISCO INC. KRX 2017-06-12 15099590639426 COULTER AcT Beckman Coulter, Inc. KRX 2016-09-23 06944904084152 SC-CAL PLUS Calibrator Shenzhen Mindray Bio-Medical Electronics Co., Ltd. KRX 2016-09-23 20844509000314 Cal-Chex A Plus STRECK, INC. KRX 2016-09-16 30844509000311 Cal-Chex A Plus STRECK, INC. KRX 2016-09-16 40844509000318 Cal-Chex A Plus STRECK, INC. KRX 2016-09-16 00817274020258 Drew Scientific DREW SCIENTIFIC, INC. KRX 2016-09-09 00380740119843 CELL-DYN ABBOTT LABORATORIES KRX 2016-09-09 00856605006004 MINOCAL HORIBA INSTRUMENTS INCORPORATED KRX 2016-08-10 00856605006103 MINOCAL HORIBA INSTRUMENTS INCORPORATED KRX 2016-08-10 14987562460325 XN CAL SYSMEX CORPORATION KRX 2016-08-04 14987562460349 XN CAL PF SYSMEX CORPORATION KRX 2016-08-04 14987562460585 X-CAL Calibrator SYSMEX CORPORATION KRX 2016-08-04 10815762020473 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 10815762020503 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 10815762020541 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 10815762020930 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 10815762021166 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 20815762020470 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 20815762020937 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 30815762020477 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 00815762020483 Research and Diagnostic Systems RESEARCH AND DIAGNOSTIC SYSTEMS, INC. KRX 2016-07-29 00380740017071 CELL-DYN ABBOTT LABORATORIES KRX 2016-06-06
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