Cepheid Xpert® HBV Viral Load - HSA Registration DE0504214
Access comprehensive regulatory information for Cepheid Xpert® HBV Viral Load 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 DE0504214 and owned by Cepheid AB. The device was registered on March 11, 2020.
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 HBV Viral Load (VL) assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis B Virus (HBV) DNA in human serum or plasma (EDTA) from chronically HBV-infected individuals using the automated GeneXpert Systems. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiviral treatment as measured by changes in plasma or serum HBV DNA levels. The test is not intended to be used as a donor screening test for HBV, or to be used as a diagnostic test to confirm the presence of HBV infection.