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Mycobacteria IVDs - ARTG 373574

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 registered under ARTG number 373574 and 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.

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Class IIb
ARTG 373574
Class IIb
Mycobacteria IVDs
ARTG ID: 373574
Good Name: Abbott Rapid Diagnostics Pty Ltd - Mycobacteria IVDs
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Intended Purpose

The Biolineโ„ข 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.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
373574
Start Date
August 26, 2021
Effective Date
August 26, 2021
Manufacturer
Country
South Korea
Address
65 Borahagal-ro Giheung-gu Yongin-si Gyeonggi-do, Korea, 17099