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Interpretive software IVDs - ARTG 441912

Access comprehensive regulatory information for Interpretive software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 441912 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Trek Diagnostic Systems Ltd in United Kingdom. The device registration started on February 21, 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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TGA ARTG Official Data
Class IIa
ARTG 441912
Class IIa
Interpretive software IVDs
ARTG ID: 441912
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Interpretive software IVDs
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Intended Purpose

In vitro diagnostic software devices intended to be used for qualitative identification of infectious agents

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
441912
Start Date
February 21, 2024
Effective Date
February 21, 2024
Manufacturer
Country
United Kingdom
Address
Units 17-19 Birches Industrial Estate, East Grinstead, West Sussex, RH19 1XZ