Device Dossier

Clinical chemistry enzyme IVDs

Device Dossier for Clinical chemistry enzyme IVDs (CT827 - Clinical chemistry enzyme IVDs, Class 2, sponsor Helena Laboratories). ARTG record, intended…

Intended purpose

IVDs that are intended to be used for the qualitative and/or quantitative determination of clinical chemistry enzymes in a clinical specimen. IDK® PMN-Elastase ELISA forthe in vitro determination of PMN elastase in stool. IDK® Pancreatic Elastase ELISA For the in vitro determination of human pancreatic elastase in stool

TGA Public Summary