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Fibrinolysis IVDs - ARTG 462846

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.

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Class IIa
ARTG 462846
Class IIa
Fibrinolysis IVDs
ARTG ID: 462846
Good Name: Abacus dx Pty Ltd - Fibrinolysis IVDs
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
462846
Start Date
September 25, 2024
Effective Date
September 25, 2024
Manufacturer
Country
Canada
Address
1781 75th Avenue West, Vancouver, British Col, V6P 6P2