Device Dossier

Human genetics-related IVDs

Device Dossier for Human genetics-related IVDs (CT906 - Human genetics-related IVDs, Class 3, sponsor ESL Biosciences Australia 2012). ARTG record,…

Intended purpose

The test enables qualitative molecular genetic in-vitro determination of human genetic characteristics directly from EDTA blood (direct method) or DNA isolated from EDTA blood. The product is designed for use by healthcare professionals. It is processed semi-automatically or manually and evaluated automatically. The test should not be used for tissue typing.

TGA Public Summary