Device Dossier

Clinical chemistry hormone IVDs

Device Dossier for Clinical chemistry hormone IVDs (CT850 - Clinical chemistry hormone IVDs, Class 2, sponsor Australian Scientific Enterprise). ARTG…

Intended purpose

Australian Scientific Enterprise Pty Ltd (ASE) produces a range of kits, calibrators and controls that are intended to be used for the qualitative and/or quantitative determination of clinical chemistry hormones in a clinical specimen.

TGA Public Summary