Bacterial infectious disease IVDs
Access comprehensive regulatory information for Bacterial infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Australian Rickettsial Reference Laboratory Foundation Ltd, manufactured by Cortez Diagnostic Inc in United States of America. The device registration started on November 30, 2016.
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 Diagnostic Automation/ Cortez Diagnostics, Inc B. burgdorferi IgG/IgM IFA test system is designed for the qualitative and semi-quantitative presumptive detection of antibodies (IgG and IgM) to Borrelia burgdorferi in human serum. Equivocal or positive results must be supplemented by testing with a standardized Western blot procedure. The testing is performed in the diagnostic laboratory environment. Limitations include possible cross-reaction with other spirochetes.