Bio-Rad Access HIV combo V2 - HSA Registration DE0508250
Access comprehensive regulatory information for Bio-Rad Access HIV combo V2 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 DE0508250 and owned by Bio-Rad France. The device was registered on June 28, 2023.
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 Access HIV combo V2 assay is a paramagnetic-particle, semi-quantitative chemiluminescent immunoassay (CLIA) for the detection of HIV-1 p24 and HIV-2 p26 antigens and antibodies to HIV-1 and HIV-2 in human serum or plasma using the Access Immunoassay Systems. This assay is intended to be used as an aid in the diagnosis of HIV infection and as a screening tool for blood and plasma donors.