ARTG 459346Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 459346 · Shield Right Pty Ltd · Hangzhou Clongene Biotech Co Ltd · Class IIb · Started August 13, 2024
Good Name: Shield Right Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 459346
- Start Date
- August 13, 2024
- Effective Date
- August 14, 2024
- Country
- China
- Address
- No 1 Yichuang Road Yuhang Sub district, Yuhang District, Hangzhou, 311121
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals. The test is an aid for diagnosis of COVID-19. Intended for self-testing by lay persons (nasal swabs).
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 registered under ARTG number 459346 and sponsored by Shield Right Pty Ltd, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on August 13, 2024.
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.