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…

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.

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