Australia TGA ARTG record

Clinical chemistry biological screening IVDs

Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Korea Inc · Class IIa · Started September 23, 2015

Good Name: Abbott Rapid Diagnostics Pty Ltd T/A Alere - Clinical chemistry biological screening IVDs

Device classification

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

Registration information

Start Date: September 23, 2015
Effective Date: September 11, 2020

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

IVDs intended for the qualitative and/or quantitative screening of urine for chemical, cellular and/or other components.

About this record

Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Korea Inc in South Korea. The device registration started on September 23, 2015.

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.