Cepheid Xpert® Carba-R - HSA Registration DE0019114
Access comprehensive regulatory information for Cepheid Xpert® Carba-R 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 DE0019114 and owned by Cepheid. The device was registered on March 30, 2017.
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 Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for rapid detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP-1 gene sequences associated with carbapenem-non-susceptibility in gram-negative bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. The test utilizes automated real-time polymerase chain reaction (PCR). The Xpert Carba-R Assay is intended to aid in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenemnon- susceptible bacterial infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory identification of carbapenem-non-susceptible bacteria.