Australia TGA ARTG record

Multiple-viruses IVDs

Australia TGA ARTG Registered Device · Emergence Technology Pty Ltd · Assure Tech (Hangzhou) Co Ltd · Class IIb · Started April 18, 2023

Good Name: Emergence Technology Pty Ltd - Multiple-viruses IVDs

Device classification

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

Registration information

Start Date: April 18, 2023
Effective Date: December 06, 2023

Sponsor

Name: Emergence Technology Pty Ltd

Manufacturer

Name: Assure Tech (Hangzhou) Co Ltd
Country: China
Address: Building 4 No 1418-50 Moganshan Road Gongshu District, Hangzhou, Zhejiang, 310011

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.

About this record

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 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.