Viral infectious disease IVDs - ARTG 374673
Access comprehensive regulatory information for Viral infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 374673 and sponsored by Bio-Rad Laboratories Pty Ltd, manufactured by Exact Diagnostics LLC in United States of America. The device registration started on September 15, 2021.
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.
IVD unassayed controls intended to be used to monitor the performance of molecular assays to provide information and means of estimating precision and has the potential for detecting systematic deviations from specific laboratory testing procedure about infection with or exposure to one or a number of viral diseases.