Red cell metabolic enzyme IVDs
Access comprehensive regulatory information for Red cell metabolic enzyme IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb 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 Test is an in vitro enzymatic colorimetric method for the semi-quantitative measurement of total hemoglobin concentration and G6PD enzymatic activity in a human fresh whole blood specimen. 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 STANDARD G6PD Test has not been validated for use with neonatal samples. This STANDARD G6PD Test is for professional use only. Specimens that generate deficient results should be considered with other clinical history available to the physician and confirmatory test methods to verify the deficiency.