Free DNA Fetal Kit ® RhD – Duplex - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT)
Access comprehensive regulatory information for Free DNA Fetal Kit ® RhD – Duplex - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT) in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Bio-Strategy Pty Ltd, manufactured by Institut de Biotechnologies Jacques Boy in France. The device registration started on February 19, 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.
This kit is an in vitro diagnostic medical device used to determine the fetal RHD genotype from a maternal blood sample taken during prenatal monitoring of RhD-negative patients, whether immunised or non-immunised, from the 11th week of amenorrhoea.