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Infectious disease IVDs

Access comprehensive regulatory information for Infectious disease IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Asquith Diagnostics Pty Ltd, manufactured by Fujirebio Europe NV in Belgium. The device registration started on November 18, 2020.

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 I
Class I
Infectious disease IVDs
Australia TGA ARTG Registered Device
Good Name: Asquith Diagnostics Pty Ltd - Infectious disease IVDs
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Intended Purpose

INNOTEST HIV Antigen mAb (96T and 480T) are enzyme immunoassay (EIA) for the qualitative detection of p24 core antigens of the human immunodeficiency virus type 1 (HIV-1), HIV-1 group O, and type 2 (HIV-2) in human serum, plasma, or cell culture supernatant.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD-Export
Registration Information
Start Date
November 18, 2020
Effective Date
November 18, 2020
Manufacturer
Country
Belgium
Address
Technologiepark 6, Gent, 9052