Haematology calibrator/control IVDs - ARTG 461373
Access comprehensive regulatory information for Haematology calibrator/control IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 461373 and sponsored by Revvity Pty Ltd, manufactured by Wallac Oy in Finland. The device registration started on August 29, 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.
The kit is intended to be used as a control in isoelectric focusing on electrophoresis gels. Relative positions of hemoglobin variants A, F, S, and C in the control are used in monitoring assay performance acceptability and in qualitative identification of normal and variant hemoglobin in human blood samples. The kit is intended to be used by trained laboratory personnel.