Plasmodium (malaria) IVDs - ARTG 422690
Access comprehensive regulatory information for Plasmodium (malaria) IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 422690 and sponsored by Abacus dx Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on September 27, 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.
STANDARD Q Malaria Tests are a rapid and membrane based immmunochromatography for qualitative detection of malaria in human capillary and venous whole blood specimens. This product is not intended for self-testing.