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Multiple-viruses IVDs - ARTG 458106

Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 458106 and sponsored by GXN Group, manufactured by Hangzhou Realy Tech Co Ltd in China. The device registration started on August 01, 2024.

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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Class IIb
ARTG 458106
Class IIb
Multiple-viruses IVDs
ARTG ID: 458106
Good Name: GXN Group - Multiple-viruses IVDs
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DJ Fang

DJ Fang

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Intended Purpose

In vitro diagnostic test for the qualitative detection of novel coronavirus antigens, influenza A & B antigens, RSV antigens, Adv antigens in Nasopharyngeal swab, using the rapid immunochromatographic method as an aid in diagnosis of symptomatic individuals. Intended for use at the point of care by trained health professionals.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
458106
Start Date
August 01, 2024
Effective Date
August 26, 2024
Sponsor
Manufacturer
Country
China
Address
#2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200