ARTG 333161Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 333161 · Abacus dx Pty Ltd · CerTest Biotec SL · Class IIb · Started April 02, 2020
Good Name: Abacus dx Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 333161
- Start Date
- April 02, 2020
- Effective Date
- January 18, 2023
- Country
- Spain
- Address
- Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840
Identification and differentiation of Coronavirus (SARS-CoV-2) in respiratory samples including the 2019 Novel COVID-19
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 333161 and sponsored by Abacus dx Pty Ltd, manufactured by CerTest Biotec SL in Spain. The device registration started on April 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.