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…
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.
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1).
Record
Regulatory record for CDS-LTX Primer | Listed by | Clinical Diagnostic Solutions, Inc., United States |
| FDA product code | KRY |
| Device type | Calibrator For Platelet Counting |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8175 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K993375 |
| Record published | 2016-09-08 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 4 to 35 °C |
| UDI direct marking | Exempt |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.