Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Abacus dx Pty Ltd · CerTest Biotec SL · Class I · Started March 17, 2022

Good Name: Abacus dx Pty Ltd - Instrument/analyser IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: March 17, 2022
Effective Date: March 17, 2022

Sponsor

Name: Abacus dx Pty Ltd

Manufacturer

Name: CerTest Biotec SL
Country: Spain
Address: Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840

Intended purpose

Real Time PCR Systems for scaling up research and high sample throughput in diagnostic lab applications

About this record

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Abacus dx Pty Ltd, manufactured by CerTest Biotec SL in Spain. The device registration started on March 17, 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.