COVID-19 test kits included in the ARTG for legal supply in Australia

The TGA has approved the following tests for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Only the approved Sponsor (i.e. importer) listed in the ARTG, or a person acting on their behalf (i.e. the person has a distribution arrangement with the sponsor), can supply the test.

Please 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.

COVID-19 test kits

Please note:

• Conditions have been imposed on the supply of COVID-19 rapid antigen point-of-care tests, COVID-19 rapid antigen self-tests (home use tests) and COVID-19 serology point-of-care tests. Further information can be found at: Legal supply of COVID-19 test kits.

• For guidance on understanding the key considerations for establishing COVID-19 rapid antigen point-of-care testing in your workplace, see COVID-19 Rapid Antigen Point-of-Care Tests – Guidance for implementation and checklist for businesses.

• The Peter Doherty Institute for Infection and Immunity (the Doherty Institute) has been engaged by the Department of Health to assist with the post-market validation of new COVID-19 rapid antibody tests to inform their best use.

• The TGA is undertaking a post-market review on the ability of COVID-19 tests to detect emerging genetic variants of SARS-CoV-2 for all COVID tests in the ARTG.

• COVID-19 tests suspended from the ARTG are published on the TGA website – Medical devices and IVDs: Suspension from the ARTG.

For more information please contact us at COVIDtests@tga.gov.au or 1800 141 144.