Australia TGA ARTG record

Software IVDs

Australia TGA ARTG Registered Device · Abbott Australasia Pty Ltd Diagnostic Division · Abbott Laboratories (USA) · Class I · Started May 13, 2022

Good Name: Abbott Australasia Pty Ltd Diagnostic Division - Software IVDs

Device classification

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

Registration information

Start Date: May 13, 2022
Effective Date: May 13, 2022

Sponsor

Name: Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Name: Abbott Laboratories (USA)
Country: United States of America
Address: 4551 Great American Pkwy, Santa Clara, California, 95054

Intended purpose

Software intended to influence an IVD Instrument/Analyser

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 Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Laboratories (USA) in United States of America. The device registration started on May 13, 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.