CDS-LTX CONTROL 502-006

GUDID 00812137010254

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.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Reticulocyte count IVD, control Reticulocyte count IVD, control

• Primary Device ID: 00812137010254
• NIH Device Record Key: 1d5a7200-7d5d-4cda-9a8d-6faa743dac5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDS-LTX CONTROL
• Version Model Number: 6 x 16 mL
• Catalog Number: 502-006
• Company DUNS: 048144997
• Company Name: CLINICAL DIAGNOSTIC SOLUTIONS, INC.
• Device Count: 6
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004533328
• Email: quality@cdsolinc.com
• Phone: 8004533328
• Email: quality@cdsolinc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812137010254 [Primary]
GS1	00812137011824 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993375

FDA Product Code

• KRX: Calibrator For Cell Indices

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-08

Devices Manufactured by CLINICAL DIAGNOSTIC SOLUTIONS, INC.

• 00001812701208 - Triglycerides Reagent: 2020-03-31 For the in vitro quantitative determination of Triglycerides in serum or plasma. Triglycerides determinations are of interest in
• 00812137011848 - Albumin Reagent: 2020-03-31 For the quantitative determination of Albumin in serum.
• 00812137010254 - CDS-LTX CONTROL: 2018-07-06CDS-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.
• 00812137010254 - CDS-LTX CONTROL: 2018-07-06 CDS-LTX Control is used to validate volume, conductivity and light scatter parameters on COULTER HmX/ MAXM, STKS and GEN-S in
• 00812137010261 - CDS-LTX PRIMER: 2018-07-06 CDS-LTX Primer is used to prepare the tubing and instrument components on the COULTER HmX/MAXM, STKS and GEN-S instruments pr
• 00812137011947 - Carbon Dioxide Reagent: 2018-06-11 For the quantitative determination of Carbon Dioxide in serum. For in vitro diagnostic use only.
• 00812137011916 - Urea Nitrogen Reagent Set: 2018-04-17 For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen
• 00081213701184 - Albumin Reagent: 2018-03-29 For the quantitative determination of Albumin in serum.
• 00812137010216 - Boule Con-Diff Tri-Level: 2018-03-29 For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff T