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Clinical chemistry-specific protein IVDs - ARTG 317823

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 registered under ARTG number 317823 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 317823
Class IIa
Clinical chemistry-specific protein IVDs
ARTG ID: 317823
Good Name: Abacus dx Pty Ltd- Clinical chemistry-specific protein IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
317823
Start Date
May 22, 2019
Effective Date
May 22, 2019
Manufacturer
Country
Ireland
Address
Fort Henry Business Park Ballina, Co Tipperary