Australia TGA ARTG record

Plasmodium (malaria) IVDs - Plasmodium (malaria) IVDs

Australia TGA ARTG Registered Device · Abbott Rapid Diagnostics Pty Ltd · Abbott Diagnostics Korea Inc · Class IIb · Started December 17, 2015

Good Name: Abbott Rapid Diagnostics Pty Ltd T/A Alere - Plasmodium (malaria) IVDs

Device classification

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

Registration information

Start Date: December 17, 2015
Effective Date: February 25, 2021

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 to aid in the detection of Plasmodium species and/or diagnosis of infection with Plasmodium species in human clinical specimens.

About this record

Access comprehensive regulatory information for Plasmodium (malaria) IVDs - Plasmodium (malaria) IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Abbott Rapid Diagnostics Pty Ltd, manufactured by Abbott Diagnostics Korea Inc in South Korea. The device registration started on December 17, 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.