Multiple-viruses IVDs
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 sponsored by BIO TOP Pty Ltd, manufactured by Hangzhou Fanttest Biotech Co Ltd in China. The device registration started on January 15, 2024.
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 Influenza A/B and the novel coronavirus SARS-CoV-2 from symptomatic individuals at the point of care by trained health professionals (nasal swab) and for self-testing by lay persons (nasal swab).