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Interpretive software IVDs - ARTG 383763

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 IIb is registered under ARTG number 383763 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Life Technologies Corporation in United States of America. The device registration started on February 09, 2022.

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 383763
Class IIb
Interpretive software IVDs
ARTG ID: 383763
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Interpretive software IVDs
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Intended Purpose

A software intended to be used for automatic interpretation of genetic analysis results from the TaqPath COVID-19 Combo Kit resulting in a diagnosis with minimum risk of user interpretation error.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
383763
Start Date
February 09, 2022
Effective Date
February 09, 2022
Manufacturer
Country
United States of America
Address
6055 Sunol Boulevard, Pleasonton, California, 94566