ARTG 481205Devyser RHD 8-R060-78 8-R060-390 - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT)
ARTG ID: 481205 · Abacus dx Pty Ltd · Devyser AB · Class III · Started February 28, 2025
Good Name: Abacus dx Pty Ltd - Devyser RHD 8-R060-78 8-R060-390 - Foetal blood group genotyping IVD, kit, nucleic acid technique (NAT)
- Risk Class
- Class III
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 481205
- Start Date
- February 28, 2025
- Effective Date
- February 28, 2025
- Name
- Devyser AB
- Country
- Sweden
- Address
- Branningevagen 12, Arsta, 120 54
Devyser RHD is a qualitative real-time PCR test for the detection of RHD present in cell-free DNA (cfDNA) in human plasma. The device is an in vitro diagnostic product intended to determine RhD feto-maternal blood group incompatibility in plasma obtained from pregnant women who have been determined as RhD negative.
Access comprehensive regulatory information for Devyser RHD 8-R060-78 8-R060-390 - 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 registered under ARTG number 481205 and sponsored by Abacus dx Pty Ltd, manufactured by Devyser AB in Sweden. The device registration started on February 28, 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.