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Geenius HCV Supplemental Controls - Hepatitis C virus total antibody IVD, control

Access comprehensive regulatory information for Geenius HCV Supplemental Controls - Hepatitis C virus total antibody IVD, control 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.

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TGA ARTG Official Data
Class III
Class III
Geenius HCV Supplemental Controls - Hepatitis C virus total antibody IVD, control
Australia TGA ARTG Registered Device
Good Name: Bio-Rad Laboratories Pty Ltd - Geenius HCV Supplemental Controls - Hepatitis C virus total antibody IVD, control
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Intended Purpose

For monitoring system performance of the Geenius HCV Supplemental Assay.

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