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Dengue virus IVDs

Access comprehensive regulatory information for Dengue virus 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 08, 2021.

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
Dengue virus IVDs
Australia TGA ARTG Registered Device
Good Name: Abacus dx Pty Ltd - Dengue virus IVDs
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Intended Purpose

IVDs that are intended to be used in testing to provide information about infection with or exposure to Dengue virus. Dengue virus NS1 antigen, IgG/IgM.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
September 08, 2021
Effective Date
September 08, 2021
Manufacturer
Country
South Korea
Address
C-4th & 5th 16 Deogyeong-daero 1556beon-gil Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690