Thrombophilia and coagulation inhibitor IVDs - ARTG 480806
Access comprehensive regulatory information for Thrombophilia and coagulation inhibitor IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 480806 and sponsored by Elitechgroup Australia Pty Ltd, manufactured by ELITechGroup SpA in Italy. The device registration started on February 25, 2025.
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 product Coagulation ELITe MGB® Kit is an in vitro diagnostic medical device intended to be used as qualitative nucleic acids RealTime PCR assay for the allelic discrimination of the following three loci in human genomic DNA samples extracted from clinical specimens: - coagulation Factor V gene, single nucleotide polymorphism (SNP) G1691A (Leiden), - coagulation Factor II gene, SNP G20210A, - 5,10-methylenetetrahydrofolate reductase (MTHFR) gene, SNP C677T. The product is intended for use as an aid in assessing the risk of deep vein thrombosis in patients suspected of having coagulation disorders and at risk of deep vein thrombosis.