Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Korea Inc · Class I · Started September 26, 2023

Good Name: Abbott Rapid Diagnostics Pty Ltd - Instrument/analyser IVDs

Device classification

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

Registration information

Start Date: September 26, 2023
Effective Date: September 26, 2023

Sponsor

Name: Abbott Rapid Diagnostics Pty Ltd

Manufacturer

Name: Abbott Diagnostics Korea Inc
Country: South Korea
Address: 65 Borahagal-ro Giheung-gu Yongin-si Gyeonggi-do, Korea, 17099

Intended purpose

Analysers intended to be used as in vitro diagnostic medical devices

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 Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Korea Inc in South Korea. The device registration started on September 26, 2023.

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.