Device Dossier

Clinical chemistry biological screening IVDs

Device Dossier for Clinical chemistry biological screening IVDs (CT1236 - Clinical chemistry biological screening IVDs, Class 2, sponsor Blackaby…

Intended purpose

An in-hospital / in-laboratory immunochromatographic rapid test inclusive of cassette and buffer for the qualitative detection of human haemoglobin in human faecal specimens. This kit is intended for use as an aid in the diagnosis of lower gastrointestinal pathologies such as colorectal cancer and its previous stages.

TGA Public Summary