Australia TGA ARTG record

Plasmodium (malaria) IVDs

Australia TGA ARTG Registered Device · Abacus dx Pty Ltd · SD Biosensor Inc · Class IIb · Started September 27, 2023

Good Name: Abacus dx Pty Ltd - Plasmodium (malaria) IVDs

Device classification

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

Registration information

Start Date: September 27, 2023
Effective Date: September 27, 2023

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

Name: SD Biosensor Inc
Country: South Korea
Address: C-4th & 5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690

Intended purpose

STANDARD Q Malaria Tests are a rapid and membrane based immmunochromatography for qualitative detection of malaria in human capillary and venous whole blood specimens. This product is not intended for self-testing.

About this record

Access comprehensive regulatory information for Plasmodium (malaria) IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Abacus dx Pty Ltd, manufactured by SD Biosensor Inc in South Korea. The device registration started on September 27, 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.