Bio-Rad Geenius HIV 1/2 Confirmatory Assay - HSA Registration DE0016728
Access comprehensive regulatory information for Bio-Rad Geenius HIV 1/2 Confirmatory Assay 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 DE0016728 and owned by Bio-Rad. The device was registered on January 09, 2015.
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 Bio-Rad Geenius™ HIV 1/2 Confirmatory Assay is a single-use immunochromatographic test for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma samples. The Geenius™ HIV 1/2 Confirmatory Assay is intended for use as an additional test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens found to be repeatedly reactive by screening procedures.