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Multiple-viruses IVDs - ARTG 411056

Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 411056 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Life Technologies Corporation in United States of America. The device registration started on June 22, 2023.

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 411056
Class IIb
Multiple-viruses IVDs
ARTG ID: 411056
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

For the qualitative detection of nucleic acid from the SARS-CoV-2 virus, the influenza A/B viruses, and the respiratory syncytial virus (RSV) from individuals showing symptoms of respiratory tract infection

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
411056
Start Date
June 22, 2023
Effective Date
June 22, 2023
Manufacturer
Country
United States of America
Address
6055 Sunol Boulevard, Pleasonton, California, 94566