Viral infectious disease IVDs - ARTG 427495
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 427495 and sponsored by Bio-Rad Laboratories Pty Ltd, manufactured by Exact Diagnostics LLC in United States of America. The device registration started on November 07, 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.
IVD unassayed controls intended to be used with specific molecular assays to monitor the performance of that given assay. These controls are used to monitor the presence/absence of one or a number of viruses. Routine use of these controls allows laboratories to evaluate their molecular assays and operator proficiency.