Device Dossier
Clinical chemistry enzyme IVDs
Device Dossier for Clinical chemistry enzyme IVDs (CT827 - Clinical chemistry enzyme IVDs, Class 2, sponsor Fujifilm). ARTG record, intended purpose,…
- GMDN category: CT827 - Clinical chemistry enzyme IVDs
Intended purpose
Quantitative measurement of alkaline phosphatase, amylase, cholinesterase, creatine phosphokinase, ?-glutamyltransferase, glutamic oxalacetic transaminase (aspartate aminotransferase), glutamic pyruvic transaminase (alanine aminotransferase), leucine aminopeptidase, lactate dehydrogenase activity in plasma or serum. For in vitro diagnostic use only.