Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 420690
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 420690 and sponsored by Pure Sponsor Pty Ltd, manufactured by Shanghai BioGerm Medical Technology Co Ltd in China. The device registration started on August 31, 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.
This kit is designed for in vitro qualitative detection of the novel coronavirus (2019-nCoV) ORF1ab and N genes in nasopharyngeal swabs and oropharyngeal swabs from suspected cases of novel coronavirus pneumonia, clusters, and other persons requiring diagnosis or differential diagnosis of novel coronavirus infection. The test results of this kit are for an aid to diagnosis only and should not be used as the sole criteria for clinical diagnosis. It is suggested that the patient's clinical manifestations and other laboratory tests should be to make a comprehensive analysis of the condition.