Instrument/analyser IVDs
Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abacus dx Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on July 01, 2024.
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.
IVD analyzers for measuring quantitative or qualitative biomarkers in body fluids such as blood, urine, and nasal mucus in laboratory and point-of-care settings by healthcare professionals only. The analyzers should be used with the specified test device or cartridge manufactured by SD BIOSENSOR Inc, as described in the package insert instructions of that specific test.