Infectious disease IVDs - ARTG 422431
Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 422431 and sponsored by Qiagen Pty Ltd, manufactured by Qiagen GmbH in Germany. The device registration started on September 25, 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.
The QIAstat-Dx Meningitis/Encephalitis (ME) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the QIAstat-Dx system. The panel is capable of simultaneous detection and identification of multiple bacterial, viral and yeast nucleic acids from cerebrospinal fluid (CSF) specimens obtained by lumbar puncture from individuals with signs / symptoms of meningitis and/or encephalitis.