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Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 462691

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 462691 and sponsored by Touch Biotechnology Pty Ltd, manufactured by Vitrosens Biyoteknoloji LTD STI in Turkey. The device registration started on September 24, 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 IIb
ARTG 462691
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 462691
Good Name: Touch Biotechnology Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
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DJ Fang

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Intended Purpose

Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals for self-testing by lay persons (nasal swab).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
462691
Start Date
September 24, 2024
Effective Date
September 24, 2024
Manufacturer
Country
Turkey
Address
Serifali Mah Sht Sk No 17/1, Umraniye, Istanbul