Device Dossier

Clinical chemistry substrate IVDs

Device Dossier for Clinical chemistry substrate IVDs (CT833 - Clinical chemistry substrate IVDs, Class 2, sponsor Inmunotek). ARTG record, intended…

Intended purpose

The NIOX Test Kits contain a sensor and bacterial / viral filters and the NIOX VERO Nasal test kits include a nasal adapter and a bacterial / viral filter. Both are accessories to the NIOX family of Airway Inflammation Monitors which measure Nitric Oxide in human breath either via the breathing handle (measuring fractional exhaled nitric oxide (FeNO) ) or using the Nasal adapter using aspirated air from the nasal cavity.

TGA Public Summary