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Multiple-viruses IVDs - ARTG 475465

Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 475465 and sponsored by Elitechgroup Australia Pty Ltd, manufactured by ELITechGroup SpA in Italy. The device registration started on January 10, 2025.

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 475465
Class IIb
Multiple-viruses IVDs
ARTG ID: 475465
Good Name: Elitechgroup Australia Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

The product ENTEROVIRUS ELITe MGBยฎ Kit is an in vitro diagnostic medical device intended to be used by healthcare professionals as quantitative nucleic acids reverse transcription and Real-Time PCR assay for the detection and quantification of the RNA of Human Enterovirus (A, B, C, D), extracted from clinical specimens.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
475465
Start Date
January 10, 2025
Effective Date
January 10, 2025
Manufacturer
Country
Italy
Address
Corso Svizzera 185, Torino, 10149