ARTG 333341Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 333341 · APAC Security Pty Ltd · Hangzhou Clongene Biotech Co Ltd · Class IIb · Started April 05, 2020
Good Name: APAC Security Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 333341
- Start Date
- April 05, 2020
- Effective Date
- September 11, 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 at the point of care by trained health professionals (whole blood, serum, plasma, nasopharyngeal swabs and nasal swabs) and 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 333341 and sponsored by APAC Security Pty Ltd, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on April 05, 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.