bioMérieux VITEK® MS PRIME - HSA Registration DE0508070
Access comprehensive regulatory information for bioMérieux VITEK® MS PRIME in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0508070 and owned by BIOMERIEUX S.A.. The device was registered on May 04, 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.
VITEK® MS PRIME is a mass spectrometry system using matrix-assisted laser desorption/ ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS PRIME system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. The VITEK® MS PRIME system and this manual are intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.