Australia TGA ARTG record

Access HIV Combo V2 - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Australia TGA ARTG Registered Device · Bio-Rad Laboratories Pty Ltd · Bio-Rad · Class III · Started September 07, 2022

Good Name: Bio-Rad Laboratories Pty Ltd - Access HIV Combo V2 - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay

Device classification

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

Registration information

Start Date: September 07, 2022
Effective Date: September 07, 2022

Sponsor

Name: Bio-Rad Laboratories Pty Ltd

Manufacturer

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

Intended purpose

Intended use: Semi-quantitative immunoassay for the detection of HIV p24/p26 antigens and antibodies to HIV1/O/2 inhuman serum and plasma using the Access Immunoassay Systems.

About this record

Access comprehensive regulatory information for Access HIV Combo V2 - HIV1/HIV2 antigen/antibody IVD, kit, chemiluminescent immunoassay 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 September 07, 2022.

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.