Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay - ARTG 440850
Access comprehensive regulatory information for Elecsys HBeAg quant (cobas e 402/801) - Hepatitis B virus e-antigen IVD, kit, chemiluminescent immunoassay in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 440850 and sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Diagnostics GmbH in Germany. The device registration started on February 13, 2024.
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.
Immunoassay for the in vitro qualitative and quantitative determination of hepatitis B e antigen (HBeAg) in human serum and plasma. The assay can be used as an aid for the diagnosis and monitoring of patients with hepatitis B viral infection. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.