Cepheid Xpert® HIV-1 Viral Load XC - HSA Registration DE0510040
Access comprehensive regulatory information for Cepheid Xpert® HIV-1 Viral Load XC 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 DE0510040 and owned by Cepheid AB. The device was registered on November 13, 2024.
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.
Xpert® HIV-1 Viral Load XC (Extended Coverage) is an in vitro reverse transcription polymerase chain reaction (RT-PCR) test for the quantification of human immunodeficiency virus type 1 (HIV-1) RNA in human EDTA plasma using the automated GeneXpert® System. It is intended for use as an aid in clinical management of patients infected with HIV-1. Xpert® HIV-1 Viral Load XC is intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels from HIV-1 infected individuals. Xpert® HIV-1 Viral Load XC is intended to be performed by trained professional users or trained healthcare workers in laboratory or near-patient testing environments. Xpert® HIV-1 Viral Load XC is not intended to be used as a donor screening test for HIV-1 infection.