Cepheid Xpert HIV-1 Qual - HSA Registration DE0504661
Access comprehensive regulatory information for Cepheid Xpert HIV-1 Qual 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 DE0504661 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 HIV-1 Qual assay, performed on the GeneXpert Instrument Systems, is a qualitative in vitro diagnostic test designed to detect Human Immunodeficiency Virus Type 1 (HIV-1) total nucleic acids on the automated GeneXpert® Systems using human whole blood (WB) and dried blood spot (DBS) specimens from individuals suspected of HIV-1 infection and is validated for specimens across Group M (subtypes A, B, C, D, F, G, H, J, K, CRF01_AE, CRF02_AG, and CRF03_AB), Group N, and Group O. The Xpert HIV-1 Qual assay is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers. The assay is intended to be used by laboratory professionals or specifically-trained healthcare workers. The assay is not intended to be used as a blood donor screening test for HIV-1.