Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Alpha-Medics Australia Pty Ltd · Hangzhou Sejoy Electronics & Instruments Co Ltd · Class IIb · Started September 21, 2022
Good Name: Alpha-Medics Australia Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- September 21, 2022
- Effective Date
- September 21, 2022
- Country
- China
- Address
- Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100
The SARS-CoV-2 Antigen Rapid Test Cassette is a single-use test kit intended to detect the SARS-CoV-2 that causes COVID-19 with self-collected nasal swab specimen from individuals who are suspected of being infected with COVID-19 within the first 7 days of symptom onset. Results are for the detection of SARS-CoV-2 Nucleocapsid Protein Antigens. The SARS-CoV-2 Antigen Rapid Test is intended to be used as an aid in diagnosis only and is intended to be used by laypersons as a self-test for home and workplace.
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 Alpha-Medics Australia Pty Ltd, manufactured by Hangzhou Sejoy Electronics & Instruments Co Ltd in China. The device registration started on September 21, 2022.
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.