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Multiple-viruses IVDs - ARTG 407849

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 407849 and sponsored by Emergence Technology Pty Ltd, manufactured by Assure Tech (Hangzhou) Co Ltd in China. The device registration started on April 18, 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.

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Class IIb
ARTG 407849
Class IIb
Multiple-viruses IVDs
ARTG ID: 407849
Good Name: Emergence Technology Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

This COVID19 Influenza A/B Antigen Nasal Test Kit is an in vitro immunoassay. The assay is for the direct and qualitative detection of viral nucleocapsid proteins of SARS CoV 2, Influenza A virus, and Influenza B virus from nasal secretions.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
407849
Start Date
April 18, 2023
Effective Date
September 11, 2024
Manufacturer
Country
China
Address
Building 4 No 1418-50 Moganshan Road Gongshu District, Hangzhou, Zhejiang, 310011