Cepheid Xpert VanA/VanB - HSA Registration DE0503684
Access comprehensive regulatory information for Cepheid Xpert VanA/VanB 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 DE0503684 and owned by Cepheid AB. The device was registered on October 02, 2019.
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.
The Cepheid Xpert vanA/vanB Assay, performed on GeneXpert Instrument Systems, is a qualitative in vitro diagnostic test designed for rapid detection of vancomycin-resistance (vanA/vanB) genes from rectal and perianal swab specimens in patients at risk for intestinal colonization of vancomycin-resistant bacteria. The test utilizes automated real-time polymerase chain reaction (PCR) to detect the vanA and vanB genes that can be associated with Vancomycin-Resistant Enterococci (VRE). The Xpert vanA/vanB Assay is intended to aid in the recognition, prevention and control of vancomycin-resistant organism colonization in healthcare settings. The Xpert vanA/vanB Assay is not intended to diagnose VRE nor to guide or monitor treatment for VRE infections. Concomitant cultures are necessary only to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification of VRE.