Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 333341
Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 333341 and sponsored by APAC Security Pty Ltd, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on April 05, 2020.
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.
“Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals at the point of care by trained health professionals (whole blood, serum, plasma, nasopharyngeal swabs and nasal swabs) and for self-testing by lay persons (nasal swabs).”