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,…

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.

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