Cepheid Xpert® HIV-1 Qual XC - HSA Registration DE0507563
Access comprehensive regulatory information for Cepheid Xpert® HIV-1 Qual XC 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 DE0507563 and owned by Cepheid AB. The device was registered on December 01, 2022.
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 Qual XC (Extended Coverage) is an in vitro nucleic acid amplification test for the qualitative detection of human immunodeficiency virus type 1 (HIV-1) total nucleic acids, on the automated GeneXpert® System. The test is used to detect HIV-1 in human dried blood spots (DBS) and EDTA capillary or venous whole blood (WB) specimens from individuals suspected of HIV-1 infection. Xpert® HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers in infant, adolescent and adult populations. Xpert® HIV-1 Qual XC is intended to be used by laboratory professionals, trained health care professionals or other health care workers receiving appropriate training on the use of the device. This test may be used in laboratory or near-patient testing environments. The test is not intended to be used as a blood, organ or tissue donor screening test for HIV-1.