Infectious disease IVDs
Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Australia Health Products Central Pty Ltd, manufactured by Ustar Biotechnologies (Hangzhou) Ltd in China. The device registration started on April 04, 2022.
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 EasyNAT COVID 19 RNA Test is a single use test kit intended to detect the novel coronavirus SARS CoV 2 that causes COVID 19. This is a portable testing kit that can be used anywhere for home/self use with self collected anterior nasal swabs samples in individuals who are suspected of COVID 19. The assay is used for auxiliary diagnosis of SARS CoV 2 infection. This assay applies isothermal amplification and the nucleic acid lateral flow assay to detect and identify specific sequences of SARS CoV 2 RNA