6 July 2023 (as updated)
COVID-19 Rapid Antigen Test (RAT) – approved for Australia
Involution Healthcare Pty Ltd has obtained regulatory approval in Australia to import and distribute SGTi-flex COVID-19 Ag, which is a Rapid Antigen Test (RAT) used to test humans for infection with the SARS-CoV-2 virus (which is the virus that causes COVID-19 disease).
Involution Healthcare Pty Ltd is the Australian Sponsor and Distributor of the Test.
The regulatory approval was confirmed by the Therapeutic Goods Administration (TGA) in Australia arranging for the Test to be added to the Australian Register of Therapeutic Goods (ARTG). The TGA is a division of the Australian Government Department of Health and Aged Care.
The Test has ARTG ID 412813.
Test approved for Self-Test use & Point-of-Care Test
The Test has been approved for use in Australia for both:
- Self-Test use by laypersons (people who are untrained in the use of medical devices); and
- Point-of-Care Test use (also known as “Professional Test” use) only by trained laboratory staff or healthcare professionals to carry out a test on another person.
The Self-Test product is available for sale to the general public.
The Point-of-Care Test product is not available for sale to the general public. The Point-of-Care Test product is only available for sale to certain types of persons and organisations who are authorised by the Australian Government to purchase this type of product.
Importantly, the Self-Test use and the Point-of-Care Test use versions of the Test are packaged separately so that they are only used for their intended type of use.
Test is made in South Korea by Sugentech, Inc.
The Test is manufactured in South Korea by Sugentech, Inc., which is a South Korean-based biotech company using the type of technical innovation that has made South Korean manufacturing world famous for high quality, use of new technologies and reliability. In particular, one core focus of Sugentech, Inc. is to converge bio, nano and IT technologies in a complementary manner to produce a smarter digital healthcare system and improve on diagnosis systems.
Involution Healthcare Pty Ltd & Sugentech, Inc.
Involution Healthcare Pty Ltd is delighted to have worked together with its manufacturing partner, Sugentech, Inc., to enable Involution Healthcare Pty Ltd to bring this Very High Quality Test to Australia and to assist in addressing the ongoing need to test people in Australia for infection with the SARS-CoV-2 virus.
Test is available in Australia from Involution Healthcare Pty Ltd
Please contact Involution Healthcare Pty Ltd regarding any enquiries to purchase the Test in Australia.
Contact Involution Healthcare today.
Involution Healthcare Pty Ltd
Level 36 Gateway
1 Macquarie Place
Sydney NSW 2000
Australia
