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Instrument/analyser IVDs - ARTG 385770

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 registered under ARTG number 385770 and 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.

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TGA ARTG Official Data
Class I
ARTG 385770
Class I
Instrument/analyser IVDs
ARTG ID: 385770
Good Name: Abacus dx Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

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

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
385770
Start Date
March 17, 2022
Effective Date
March 17, 2022
Manufacturer
Country
Spain
Address
Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840