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Access HCV Ab V3 - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay - ARTG 288795

Access comprehensive regulatory information for Access HCV Ab V3 - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 288795 and 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.

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Class III
ARTG 288795
Class III
Access HCV Ab V3 - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
ARTG ID: 288795
Good Name: Bio-Rad Laboratories Pty Ltd - Access HCV Ab V3 - Hepatitis C virus total antibody IVD, kit, chemiluminescent assay
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Intended Purpose

For the qualitative detection of anti-HCV antibodies in human serum and plasma, using the Access Immunoassay systems.

Device Classification
Risk Class
Class III
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
288795
Start Date
May 11, 2017
Effective Date
May 11, 2017
Manufacturer
Country
France
Address
3 Boulevard Raymond Poincare, 92430 MARNES-LA-COQUETTE