Australia TGA ARTG record

Multiple-viruses IVDs

Australia TGA ARTG Registered Device · Thermo Fisher Scientific Australia Pty Ltd · Life Technologies Corporation · Class IIb · Started June 22, 2023

Good Name: Thermo Fisher Scientific Australia Pty Ltd - Multiple-viruses IVDs

Device classification

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

Registration information

Start Date: June 22, 2023
Effective Date: June 22, 2023

Sponsor

Name: Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Name: Life Technologies Corporation
Country: United States of America
Address: 6055 Sunol Boulevard, Pleasonton, California, 94566

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

About this record

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 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.