Device Dossier

Clinical chemistry biological screening IVDs

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

Intended purpose

The cassette style feacal occult blood test is a direct binding immunoassay for the rapid and qualitative detection of human occult blood in faeces. It is a screening test that requires further testing and is for professional use only.

TGA Public Summary