Device Dossier
Clinical chemistry substrate IVDs
Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Fujifilm). ARTG record, intended…
- GMDN category: CT833 - Clinical chemistry substrate IVDs
Intended purpose
Quantitative measurement of ammonia in whole blood; urea nitrogen, creatinine, direct bilrubin, glucose, high-density lipoprotein cholesterol, ammonia, total bilirubin, total cholesterol, triglyceride, uric acid concentration in plasma or serum. For in vitro diagnostic use only.