Cepheid Xpert MRSA NxG - HSA Registration DE0019077
Access comprehensive regulatory information for Cepheid Xpert MRSA NxG 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 DE0019077 and owned by Cepheid. The device was registered on March 20, 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 Xpert® MRSA NxG Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test intended for the detection of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The test utilizes automated real-time polymerase chain reaction (PCR) for the amplification of MRSA specific DNA targets and fluorogenic target-specific hybridization probes for the real-time detection of the amplified DNA. The Xpert® MRSA NxG Assay is intended to aid in the prevention and control of MRSA infections in healthcare settings. The Xpert MRSA NxG Assay is not intended to diagnose, guide, or monitor treatment for MRSA infections, or provide results of susceptibility to methicillin. A negative result does not preclude nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further antimicrobial susceptibility testing.