Device Dossier

Haemoximetry and blood gas IVDs

Device Dossier for Haemoximetry and blood gas IVDs (CT806 - Haemoximetry and blood gas 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 blood gas analytes, calculated blood gas parameters and haemoglobin complexes in a clinical specimen.

TGA Public Summary