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Clinical chemistry biological screening IVDs

Access comprehensive regulatory information for Clinical chemistry biological screening IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Touch Biotechnology Pty Ltd, manufactured by Vitrosens Biyoteknoloji LTD STI in Turkey. The device registration started on May 15, 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
Class IIa
Clinical chemistry biological screening IVDs
Australia TGA ARTG Registered Device
Good Name: Touch Biotechnology Pty Ltd - Clinical chemistry biological screening IVDs
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Intended Purpose

IVDs that are intended to be used for the qualitative screening of urine for the detection of nitrite and leukocytes which indicates the urinary tract infection. For self-test in vitro diagnostic use only.

Device Classification
Risk Class
Class IIa
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
May 15, 2024
Effective Date
May 15, 2024
Manufacturer
Country
Turkey
Address
Serifali Mah Sht Sk No 17/1, Umraniye, Istanbul