Australia TGA ARTG record

Interpretive software IVDs

Australia TGA ARTG Registered Device · Roche Diagnostics Australia Pty Limited · Roche Sequencing Solutions Inc · Class IIb · Started October 26, 2020

Good Name: Roche Diagnostics Australia Pty Limited - Interpretive software IVDs

Device classification

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

Registration information

Start Date: October 26, 2020
Effective Date: October 26, 2020

Sponsor

Name: Roche Diagnostics Australia Pty Limited

Manufacturer

Name: Roche Sequencing Solutions Inc
Country: United States of America
Address: 4300 Hacienda Drive, Pleasanton, CA, 94588

Intended purpose

Interpretative software algorithms intended to be applied to a clinical result or set of results obtained through testing in order to identify and/or formulate additional clinical information which may then be used to guide patient management

About this record

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 sponsored by Roche Diagnostics Australia Pty Limited, manufactured by Roche Sequencing Solutions Inc in United States of America. The device registration started on October 26, 2020.

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.