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Analyser software IVDs - ARTG 465145

Access comprehensive regulatory information for Analyser software IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 465145 and sponsored by Abacus dx Pty Ltd, manufactured by CerTest Biotec SL in Spain. The device registration started on October 21, 2024.

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 IIa
ARTG 465145
Class IIa
Analyser software IVDs
ARTG ID: 465145
Good Name: Abacus dx Pty Ltd - Analyser software IVDs
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Intended Purpose

VIASURE V-Smart is a stand-alone software that supports the automated interpretation, analysis and visualization of quantitative and qualitative Real-Time PCR Cycler raw data derived from VIASURE Real Time PCR Kits, into tests results.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
465145
Start Date
October 21, 2024
Effective Date
October 21, 2024
Manufacturer
Country
Spain
Address
Poligono Industrial Rio Gallego II Calle J No 1, San Mateo de Gallego, Zaragoza, 50840