Pure Global

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

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class III
Class III
Geenius HCV Supplemental Assay - Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid
Australia TGA ARTG Registered Device
Good Name: Bio-Rad Laboratories Pty Ltd - Geenius HCV Supplemental Assay - Hepatitis C virus total antibody IVD, kit, immunochromatographic test (ICT), rapid
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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.

Device Classification
Risk Class
Class III
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
October 28, 2020
Effective Date
October 28, 2020
Manufacturer
Country
France
Address
3 Boulevard Raymond Poincare, 92430 MARNES-LA-COQUETTE