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.

CDS
CDS-LTX PRIMER - 6 x 16mL

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: KRY

Device Name: Calibrator For Platelet Counting

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.8175

Third Party Flag: N

Medical Specialty: HE

Device Id: 00812137010261

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 00812137011831

Device Type: Unit of Use

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A