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Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 333161

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.

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Class IIb
ARTG 333161
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 333161
Good Name: Abacus dx Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
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Intended Purpose

Identification and differentiation of Coronavirus (SARS-CoV-2) in respiratory samples including the 2019 Novel COVID-19

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
333161
Start Date
April 02, 2020
Effective Date
January 18, 2023
Manufacturer
Country
Spain
Address
Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840