Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Abbott Australasia Pty Ltd Diagnostic Division · Abbott Laboratories (USA) · Class I · Started May 09, 2022

Good Name: Abbott Australasia Pty Ltd Diagnostic Division - Instrument/analyser IVDs

Device classification

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

Registration information

Start Date: May 09, 2022
Effective Date: May 09, 2022

Sponsor

Name: Abbott Australasia Pty Ltd Diagnostic Division

Manufacturer

Name: Abbott Laboratories (USA)
Country: United States of America
Address: 1921 Hurd Drive, Irving, Texas, 75038

Intended purpose

Instrument/Analyser intended to be used as an in vitro diagnostic (IVD) medical device

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 Abbott Australasia Pty Ltd Diagnostic Division, manufactured by Abbott Laboratories (USA) in United States of America. The device registration started on May 09, 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.