Australia TGA ARTG record

Access HCV V3 Calibrators - Hepatitis C virus total antibody IVD, calibrator

Australia TGA ARTG Registered Device · Bio-Rad Laboratories Pty Ltd · Bio-Rad · Class III · Started May 11, 2017

Good Name: Bio-Rad Laboratories Pty Ltd - Access HCV V3 Calibrators - Hepatitis C virus total antibody IVD, calibrator

Device classification

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

Registration information

Start Date: May 11, 2017
Effective Date: May 11, 2017

Sponsor

Name: Bio-Rad Laboratories Pty Ltd

Manufacturer

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

Intended purpose

The Access HCV V3 Calibrators are intended to calibrate the Access HCV Ab V3 assay using the Access Immunoassay Systems.

About this record

Access comprehensive regulatory information for Access HCV V3 Calibrators - Hepatitis C virus total antibody IVD, calibrator 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 May 11, 2017.

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.