We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
These tests have been approved for the Australian Register of Therapeutic Goods (ARTG).
A test can only be supplied by the approved Sponsor (i.e., importer) listed in the ARTG, or by someone acting on their behalf.
Refer to the instructions for use for each test to determine intended specimen types.
COVID-19 test kits in the ARTG
Click on the button below to view COVID-19 test kits included in the ARTG for legal supply in Australia.
More information
- COVID-19 rapid antigen point-of-care tests
- COVID-19 rapid antigen self-tests (home use tests)
- COVID-19 serology point-of-care tests
- Legal supply of COVID-19 test kits
- COVID-19 Rapid Antigen Point-of-Care Tests: checklist for businesses
- Ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2
- Medical devices and IVDs: Suspension from the ARTG
Contact us
For more information contact us at IVDs@tga.gov.au or 1800 141 144.