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Plasmodium (malaria) IVDs - Plasmodium (malaria) IVDs

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.

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TGA ARTG Official Data
Class IIb
Class IIb
Plasmodium (malaria) IVDs - Plasmodium (malaria) IVDs
Australia TGA ARTG Registered Device
Good Name: Abbott Rapid Diagnostics Pty Ltd T/A Alere - Plasmodium (malaria) IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
December 17, 2015
Effective Date
February 25, 2021
Manufacturer
Country
South Korea
Address
65 Borahagal-ro Giheung-gu Yongin-si Gyeonggi-do, Korea, 17099