Streptococcus IVDs - ARTG 483771
Access comprehensive regulatory information for Streptococcus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 483771 and sponsored by Aceso Diagnostics Pty Ltd, manufactured by Hangzhou Alltest Biotech Co Ltd in China. The device registration started on March 24, 2025.
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 Strep A Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigens in throat swab specimens. For near-patient and laboratory professional in vitro diagnostic use only.