Multiple-viruses IVDs - ARTG 430031
Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 430031 and sponsored by Emergence Technology Pty Ltd, manufactured by Assure Tech (Hangzhou) Co Ltd in China. The device registration started on December 06, 2023.
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.
Intended to detect Respiratory syncytial virus, Influenza A/B and the novel coronavirus SARS-CoV-2 as an aid in diagnosis from symptomatic individuals at the point of care by trained health professionals and for self-testing (nasal swab).