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Multiple-viruses IVDs - ARTG 408459

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 408459 and sponsored by Touch Biotechnology Pty Ltd, manufactured by Vitrosens Biyoteknoloji LTD STI in Turkey. The device registration started on May 04, 2023.

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 408459
Class IIb
Multiple-viruses IVDs
ARTG ID: 408459
Good Name: Touch Biotechnology Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

Intended to detect Respiratory syncytial virus (RSV), Influenza A/B and the novel coronavirus SARS-CoV-2 from symptomatic individuals for self-testing by lay persons over 2 years old (nasal swab).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
408459
Start Date
May 04, 2023
Effective Date
September 11, 2024
Manufacturer
Country
Turkey
Address
Serifali Mah Sht Sk No 17/1, Umraniye, Istanbul