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Clinical chemistry-specific protein IVDs - ARTG 463893

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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Class IIb
ARTG 463893
Class IIb
Clinical chemistry-specific protein IVDs
ARTG ID: 463893
Good Name: Abacus dx Pty Ltd - Clinical chemistry-specific protein IVDs
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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.

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
Manufacturer
Country
Canada
Address
1781 75th Avenue West, Vancouver, British Col, V6P 6P2