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 Biocelect Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on April 21, 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.
The STANDARD G6PD Analyzer is designed to measure the semi-quantitative determination of total-hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimen based on reflectometry assays. The test is intended to aid in the identification of people with G6PD deficiency providing point-of care access and allowing prompt treatment decisions. The analyzer is for in vitro diagnostic use and professional use only.