Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Integrated Sciences Pty Ltd · Dynex Technologies Inc · Class I · Started April 19, 2022

Good Name: Integrated Sciences Pty Ltd - Instrument/analyser IVDs

Device classification

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

Registration information

Start Date: April 19, 2022
Effective Date: April 19, 2022

Sponsor

Name: Integrated Sciences Pty Ltd

Manufacturer

Name: Dynex Technologies Inc
Country: United States of America
Address: 14340 Sullyfield Circle, Chantilly, VA, 20151

Intended purpose

Analyser for the processing of clinicial samples by ELISA

About this record

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Integrated Sciences Pty Ltd, manufactured by Dynex Technologies Inc in United States of America. The device registration started on April 19, 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.