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 Viramed Biotech AG in Germany. The device registration started on August 31, 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 intended use of Borrelia ViraStripe IgM and IgG test kits are for the confirmation of Lyme disease. It is generally used as a secondary test to support the findings of a Lyme immunofluorescence assay or enzyme-immunoassay. It is used for the qualitative detection of IgM and IgG antibodies against specific Borrelia antigens in human serum. The testing is performed in the diagnostic laboratory environment. Limitations include possible cross-reaction with other spirochetes.