Device Dossier

Haemoximetry and blood gas IVDs

Device Dossier for Haemoximetry and blood gas IVDs (CT806 - Haemoximetry and blood gas IVDs, Class 2, sponsor Werfen). ARTG record, intended purpose,…

Intended purpose

A whole blood oximeter test that performs individual point-of-care measurements of total hemoglobin (tHb), oxyhemoglobin saturation (%O2Hb), carboxyhemoglobin (%COHb), and methemoglobin (%MetHb) on freshly-drawn or heparin-or EDTA-anticoagulated whole blood samples.

TGA Public Summary