ARTG 426895Oncomine™Dx Target Test
ARTG ID: 426895 · Thermo Fisher Scientific Australia Pty Ltd · Life Technologies Corporation · Class IIb · Started October 25, 2023
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Oncomine™Dx Target Test
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 426895
- Start Date
- October 25, 2023
- Effective Date
- October 25, 2023
- Country
- United States of America
- Address
- 7335 Executive Way, Frederick, MD, 21704
The Oncomine™ Dx Target Test is a qualitative in vitro diagnostic test that uses high throughput parallel sequencing technology. It is indicated to detect sequence variations (SNVs, deletions, insertions, and fusions), in 26 cancer-related genes on DNA and RNA isolated from formalin-fixed paraffin-embedded embedded paraffin-embedded (FFPE) tissues. This test is indicated as a companion diagnostic to aid selecting non-small cell lung cancer (NSCLC) patients for treatment with the targeted therapies listed in the instructions for use in accordance with the approved therapeutic indications.
Access comprehensive regulatory information for Oncomine™Dx Target Test in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 426895 and sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Life Technologies Corporation in United States of America. The device registration started on October 25, 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.