Australia TGA ARTG record

Severe acute respiratory syndrome-associated coronavirus IVDs

Australia TGA ARTG Registered Device · Emergence Technology Pty Ltd · Ustar Biotechnologies (Hangzhou) Ltd · Class IIb · Started November 02, 2020

Good Name: Emergence Technology Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs

Device classification

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

Registration information

Start Date: November 02, 2020
Effective Date: January 18, 2023

Sponsor

Name: Emergence Technology Pty Ltd

Manufacturer

Name: Ustar Biotechnologies (Hangzhou) Ltd
Country: China
Address: Room 801-808 3766 Nanhuan Road Fl 8 Binjiang Dist, Hangzhou, Zhejiang, 310053

Intended purpose

This product is a diagnostic kit for Novel-Coronavirus (2019-nCoV) RNA (Isothermal Amplification-Real Time Fluorescence Assay). This product is intended to be used in testing to provide information about infection with Severe acute respiratory syndrome-associated coronavirus (SARSCoV).

About this record

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus 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 Ustar Biotechnologies (Hangzhou) Ltd in China. The device registration started on November 02, 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.