Australia TGA ARTG record

Geenius HCV Supplemental Assay - Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid

Australia TGA ARTG Registered Device · Bio-Rad Laboratories Pty Ltd · Bio-Rad · Class III · Started October 28, 2020

Good Name: Bio-Rad Laboratories Pty Ltd - Geenius HCV Supplemental Assay - Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid

Device classification

Risk Class: Class III
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: October 28, 2020
Effective Date: October 28, 2020

Sponsor

Name: Bio-Rad Laboratories Pty Ltd

Manufacturer

Name: Bio-Rad
Country: France
Address: 3 Boulevard Raymond Poincare, 92430 MARNES-LA-COQUETTE

Intended purpose

For the confirmation of the presence of antibodies associated with infection caused by Hepatitis C Virus (HCV) in human venous whole blood, serum or plasma specimen from individuals (including blood donors) or patients.

About this record

Access comprehensive regulatory information for Geenius HCV Supplemental Assay - Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Bio-Rad Laboratories Pty Ltd, manufactured by Bio-Rad in France. The device registration started on October 28, 2020.

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.