ARTG 462846Fibrinolysis IVDs
ARTG ID: 462846 · Abacus dx Pty Ltd · Response Biomedical Corporation · Class IIa · Started September 25, 2024
Good Name: Abacus dx Pty Ltd - Fibrinolysis IVDs
- Risk Class
- Class IIa
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 462846
- Start Date
- September 25, 2024
- Effective Date
- September 25, 2024
- Country
- Canada
- Address
- 1781 75th Avenue West, Vancouver, British Col, V6P 6P2
The RAMP D-Dimer test is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used in the quantification of the fibrin degradation product (FDP) D-Dimer in human EDTA anti-coagulated whole blood.
Access comprehensive regulatory information for Fibrinolysis IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 462846 and sponsored by Abacus dx Pty Ltd, manufactured by Response Biomedical Corporation in Canada. The device registration started on September 25, 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.