CDS-LTX PRIMER 502-007

GUDID 00812137010261

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.

CLINICAL DIAGNOSTIC SOLUTIONS, INC.

Reticulocyte count IVD, control Reticulocyte count IVD, control

• Primary Device ID: 00812137010261
• NIH Device Record Key: 2513eb8d-020e-4e9c-b31d-33de27aaff47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CDS-LTX PRIMER
• Version Model Number: 6 x 16mL
• Catalog Number: 502-007
• 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 4 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812137010261 [Primary]
GS1	00812137011831 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993375

FDA Product Code

• KRY: Calibrator For Platelet Counting

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: 2018-07-06 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: 2018-07-06CDS-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.
• 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