Australia flagARTG 463893

Clinical chemistry-specific protein IVDs

ARTG ID: 463893 · Abacus dx Pty Ltd · Response Biomedical Corporation · Class IIb · Started October 08, 2024

Good Name: Abacus dx Pty Ltd - Clinical chemistry-specific protein IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
463893
Start Date
October 08, 2024
Effective Date
October 08, 2024
Sponsor
Manufacturer
Country
Canada
Address
1781 75th Avenue West, Vancouver, British Col, V6P 6P2
Intended purpose

IVDs that are intended to measure levels of protein biomarkers that, in conjunction with other laboratory findings and clinical assessment, aid in the diagnosis of cardiovascular events.

About this record

Access comprehensive regulatory information for Clinical chemistry-specific protein IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 463893 and sponsored by Abacus dx Pty Ltd, manufactured by Response Biomedical Corporation in Canada. The device registration started on October 08, 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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