ARTG 408459

Multiple-viruses IVDs

ARTG ID: 408459 · Touch Biotechnology Pty Ltd · Vitrosens Biyoteknoloji LTD STI · Class IIb · Started May 04, 2023

Good Name: Touch Biotechnology Pty Ltd - Multiple-viruses IVDs

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

Sponsor

Name: Touch Biotechnology Pty Ltd

Manufacturer

Name: Vitrosens Biyoteknoloji LTD STI
Country: Turkey
Address: Serifali Mah Sht Sk No 17/1, Umraniye, Istanbul

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).

About this record

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.