Parasitic infectious diseases IVDs - ARTG 302000
Access comprehensive regulatory information for Parasitic infectious diseases IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 302000 and sponsored by Australian Rickettsial Reference Laboratory Foundation Ltd, manufactured by Fuller Laboratories in United States of America. The device registration started on April 19, 2018.
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.
IVDs designed for the detection and semiquantitation of IgG and IgM antibody to Bebesia microti in human serum. Laboratory test only. Cross-reactivity with Plasmodium spp has been documented.