Australia TGA ARTG record

Free DNA Fetal Kit ® RhD – Duplex - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT)

Australia TGA ARTG Registered Device · Bio-Strategy Pty Ltd · Institut de Biotechnologies Jacques Boy · Class III · Started February 19, 2024

Good Name: Bio-Strategy Pty Ltd - Free DNA Fetal Kit ® RhD – Duplex - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT)

Device classification

Risk Class: Class III
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: February 19, 2024
Effective Date: February 19, 2024

Sponsor

Name: Bio-Strategy Pty Ltd

Manufacturer

Name: Institut de Biotechnologies Jacques Boy
Country: France
Address: Pole Technologique Henri Farman 4 Allee Albert Caquot BP 227, Reims, 51100

Intended purpose

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.

About this record

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.