Australia TGA ARTG record

Multiple-viruses IVDs

Australia TGA ARTG Registered Device · Sonictec Pty Ltd · Jiangsu Macro & Micro-Test Med-Tech Co Ltd · Class IIb · Started September 20, 2023

Good Name: Sonictec Pty Ltd - Multiple-viruses IVDs

Device classification

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

Registration information

Start Date: September 20, 2023
Effective Date: September 20, 2023

Sponsor

Name: Sonictec Pty Ltd

Manufacturer

Name: Jiangsu Macro & Micro-Test Med-Tech Co Ltd
Country: China
Address: No 888 Zhujiang Road Juegang Street Rudong County, Life and Health Industrial Park of Rudong High-tech Zone, Nantong City, Jiangsu Province, 226499

Intended purpose

This kit is intended for in vitro qualitative detection of SARS-CoV-2, influenza A and influenza B nucleic acid of the oropharyngeal swab samples which of the people who were suspected infection of SARS-CoV-2, influenza A and influenza B. It also can be used in suspected pneumonia and suspected cluster cases and for qualitative detection and identify of SARS-CoV-2, influenza A and influenza B nucleic acid in oropharyngeal swab samples of novel Coronavirus infection in other circumstances.

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 Sonictec Pty Ltd, manufactured by Jiangsu Macro & Micro-Test Med-Tech Co Ltd in China. The device registration started on September 20, 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.