ARTG 450786Constitutional chromosomal disorder IVDs
ARTG ID: 450786 · Abacus dx Pty Ltd · Devyser AB · Class IIb · Started June 04, 2024
Good Name: Abacus dx Pty Ltd - Constitutional chromosomal disorder IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 450786
- Start Date
- June 04, 2024
- Effective Date
- June 04, 2024
- Name
- Devyser AB
- Country
- Sweden
- Address
- Instrumentvagen 19, Hagersten, 126 53
Qualitative in vitro diagnostic assay as an aid in diagnosis of aneuploidies in prenatal samples (chorionic villus (CV), amniotic fluid (AF)) such as Down, Edwards, Patau, Klinefelter Turner, XXY and Triple X syndrome.
Access comprehensive regulatory information for Constitutional chromosomal disorder IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 450786 and sponsored by Abacus dx Pty Ltd, manufactured by Devyser AB in Sweden. The device registration started on June 04, 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.