Device Dossier
Analyser software IVDs
Device Dossier for Analyser software IVDs (CT1250 - Analyser software IVDs, Class 2, sponsor Grifols). ARTG record, intended purpose, GMDN category —…
- GMDN category: CT1250 - Analyser software IVDs
- Sponsor: Grifols
Intended purpose
Collects data from Procleix systems to track individual donor samples and link them to appropriate test results. It collates results, assigns outcomes to individual samples, and formats output files. It can verify that master pool tubes have the required mass. It produces summary reports. It is used by personnel who are trained in its operation. Retesting, reflex testing, worklist population, and export of final results can all be controlled. It manages test results for the Procleix systems.