Haemoglobin IVDs - ARTG 461387
Access comprehensive regulatory information for Haemoglobin IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 461387 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 RESOLVE Systems Hemoglobin kit is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing. The kit is designed to be run on a flat-bed electrofocusing unit. This assay is intended for use as an aid in the diagnosis of neonatal and adult hemoglobinopathies.