Australia TGA ARTG record

Mycobacteria IVDs

Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Korea Inc · Class IIb · Started August 26, 2021

Good Name: Abbott Rapid Diagnostics Pty Ltd - Mycobacteria IVDs

Device classification

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

Registration information

Start Date: August 26, 2021
Effective Date: August 26, 2021

Sponsor

Name: Abbott Rapid Diagnostics Pty Ltd

Manufacturer

Name: Abbott Diagnostics Korea Inc
Country: South Korea
Address: 65 Borahagal-ro Giheung-gu Yongin-si Gyeonggi-do, Korea, 17099

Intended purpose

The Bioline™ TB Ag MPT64 is a rapid immunochromatographic identification test for the M.tuberculosis complex that uses mouse monoclonal anti-MPT64. The test kit can be easily used for rapid identification of the M.tuberculosis complex in combination with culture systems based on liquid media without any technical complexity in clinical laboratories.

About this record

Access comprehensive regulatory information for Mycobacteria IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Korea Inc in South Korea. The device registration started on August 26, 2021.

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.