Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 3, sponsor Randox). ARTG record, intended purpose,…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
Quality Control material that is intended to be used for the measurement of accuracy and precision of laboratory testing procedures for the determination of multiple clinical chemistry substrates and cardiac markers in a clinical specimen.