Australia TGA ARTG recordElecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay
Australia TGA ARTG Registered Device · Roche Diagnostics Australia Pty Limited · Roche Diagnostics GmbH · Class III · Started February 22, 2024
Good Name: Roche Diagnostics Australia Pty Limited - Elecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- February 22, 2024
- Effective Date
- February 22, 2024
- Country
- Germany
- Address
- Sandhofer Strasse 116, Mannheim, D-68305
Elecsys HCV Duo is an immunoassay for the in vitro qualitative detection of hepatitis C virus (HCV) core antigen (HCV Ag) and antibodies to HCV (anti-HCV) in human serum and plasma. The test in conjunction with other laboratory results and clinical information, may be used to aid in the diagnosis of and the screening of HCV infection. The test can also be used as a screening test to prevent transmission of HCV to recipients of blood, blood components, cells, tissue, and organs. The subresults (HCV Ag and anti-HCV) are intended as an aid in the selection of the confirmatory testing algorithm for reactive samples.The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Access comprehensive regulatory information for Elecsys HCV Duo (cobas e 402/801) - Hepatitis C virus antibody/antigen IVD, kit, chemiluminescent immunoassay in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Diagnostics GmbH in Germany. The device registration started on February 22, 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.