Neisseria IVDs
Access comprehensive regulatory information for Neisseria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Integrated Sciences Pty Ltd, manufactured by Seegene Inc in South Korea. The device registration started on September 14, 2022.
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.
Allplex NG & DR Assay is a qualitative in vitro diagnostic test for single or multiple detection of N. gonorrhoeae (NG) and the mutation of A2059G and C2611T in the 23S rRNA gene responsible for Azithromycin resistance in N. gonorrhoeae (NG), and S91F in the gyrase A responsible for Ciprofloxacin resistance in N. gonorrhoeae (NG)