Severe acute respiratory syndrome-associated coronavirus IVDs
Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Pharma Soul Pty Ltd, manufactured by iXensor Co Ltd in Taiwan. The device registration started on September 14, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
The PixoTest® COVID-19 Ag Test Kit is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 present in human nasopharynx cavity. The PixoTest® COVID-19 Ag Test Kit is designed to be used in conjunction with the PixoTest® POCT Analyser for the issuing of fully digitalised rapid SARS-CoV-2 test results. This test is single use only and the administration of the test and the interpretation of the results should be done by trained healthcare professionals only. The result of this test should not be the sole basis for the diagnosis of COVID-19; additional confirmatory testing is required.