Australia TGA ARTG record

Clinical chemistry-specific protein IVDs

Australia TGA ARTG Registered Device · Abacus dx Pty Ltd · Techno-path Manufacturing Ltd · Class IIa · Started May 22, 2019

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

Device classification

Risk Class: Class IIa
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: May 22, 2019
Effective Date: May 22, 2019

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

Name: Techno-path Manufacturing Ltd
Country: Ireland
Address: Fort Henry Business Park Ballina, Co Tipperary

Intended purpose

IVDs intended to be used for quality control, to monitor the precision of laboratory testing procedures for protein specific clinical chemistry analytes

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 IIa is sponsored by Abacus dx Pty Ltd, manufactured by Techno-path Manufacturing Ltd in Ireland. The device registration started on May 22, 2019.

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.