Sensititre System - HSA Registration DE0508388
Access comprehensive regulatory information for Sensititre System in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0508388 and owned by Trek Diagnostic Systems Ltd. The device was registered on August 16, 2023.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
All the Sensititre plates (e.g., MYCOTBI, GN6F, DKMGN) are used for antimicrobial susceptibility testing for patients and to determine which patient will be resistant or not. There are a various combination of drugs that cover all Gram positive, Gram negative, Yeast and Mycobacterium media. The plates need to be used in conjunction with the Instruments (e.g., Vizion, Opti Read, ARIS HiQ) and thus simultaneously along with the SWIN software. The reason behind this is because the software contains all the Minimum inhibition concentration (MIC) breakpoints and CLSI breakpoints needed to identify the drugs sensitivity and resistance which is then sent to a physician via the use of the SWIN Epidemiology module. This way physicians across the world can prescribe the correct antimicrobials to treat patients and to reduce the resistance to antimicrobials.