Cepheid Xpert HCV VL Fingerstick - HSA Registration DE0504662
Access comprehensive regulatory information for Cepheid Xpert HCV VL Fingerstick in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0504662 and owned by Cepheid AB. The device was registered on July 01, 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 Xpert HCV VL Fingerstick (FS) assay is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human capillary fingerstick EDTA whole blood and venous EDTA whole blood from HCV-infected individuals using the automated GeneXpert® Instrument Systems. The assay is intended for use as an aid in the initial diagnosis in individuals at high risk of HCV infection or anti-HCV positive individuals. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. The assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. The test measures HCV RNA levels at any time during viremia and during treatment; and can be utilized to predict sustained and nonsustained virological responses to HCV therapy. The assay is not intended to be used as a blood donor screening test for HCV.