Device Dossier

Container, specimen, postal transport

Device Dossier for Container, specimen, postal transport (Container, specimen, postal transport, Class IIa, sponsor Australian Clinical Laboratories).…

Intended purpose

The Healthscope collection kits are 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. The Healthscope collection kits are used for the self-collection of patient cells, fluids, tissues, etc. from various anatomical locations (including broken mucosa or skin) for testing for, but not limited to, chlamydia, gonorrhoea, respiratory infections, etc.

TGA Public Summary