Device Dossier

Container, specimen, postal transport

Device Dossier for Container, specimen, postal transport (Container, specimen, postal transport, Class IIa, sponsor GenesFX Health). ARTG record,…

Intended purpose

The GenesFX collection kit is for the self-collection and transport of patient cells, fluids, tissues, etc. to a laboratory for in vitro diagnostic (IVD) testing. The test results are reported directly back to the patient’s medical practitioner or healthcare professional.

TGA Public Summary