Australia TGA ARTG record

Software IVDs

Australia TGA ARTG Registered Device · Abacus dx Pty Ltd · Dynex Technologies Inc · Class I · Started October 22, 2020

Good Name: Abacus dx Pty Ltd - Software IVDs

Device classification

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

Registration information

Start Date: October 22, 2020
Effective Date: October 22, 2020

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

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

Intended purpose

Operating software for IVD instruments including ELISA processors

About this record

Access comprehensive regulatory information for Software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abacus dx Pty Ltd, manufactured by Dynex Technologies Inc in United States of America. The device registration started on October 22, 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.