Streptococcus IVDs - ARTG 467487
Access comprehensive regulatory information for Streptococcus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 467487 and sponsored by Touch Biotechnology Pty Ltd, manufactured by Vitrosens Biyoteknoloji LTD STI in Turkey. The device registration started on November 06, 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.
A Rapid Test integrated Device intended for the collection of a throat swab specimen and its rapid analysis by a chromatographic immunoassay for the qualitative detection of Strep A antigen to aid in the diagnosis of Group A Streptococcal infection. The test is intended to be used by health professionals or laboratory professionals at the point of care setting.