Multiple-viruses IVDs - ARTG 462295
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 462295 and sponsored by Abacus dx Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on September 17, 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.
STANDARD M10 Flu/RSV/SARS-CoV-2 test is a multiplex real-time RT-PCR test intended for use with STANDARD M10 system for aiding in the qualitative detection of Influenza A, Influenza B, RSV and SARS-CoV-2 nucleic acids in human nasopharyngeal swab collected from individuals suspected of a respiratory disease by their healthcare provider. The test is intended to be performed by trained users in both laboratory and point of care testing setting.