Bio-Rad BioPlex 2200 HIV Ag-Ab - HSA Registration DE0504581
Access comprehensive regulatory information for Bio-Rad BioPlex 2200 HIV Ag-Ab 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 DE0504581 and owned by Bio-Rad Laboratories, Inc.. The device was registered on June 10, 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 BioPlex 2200 HIV Ag-Ab assay is a multiplex flow immunoassay intended for the simultaneous qualitative detection and differentiation of HIV-1 p24 antigen, antibodies to HIV-1 (Groups M and O) and HIV-2 in human serum or plasma. This kit is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2, including acute or primary HIV-1 infection. The BioPlex 2200 HIV Ag-Ab assay can also be used to screen blood and plasma donors. The BioPlex 2200 HIV Ag-Ab assay is intended for use with the BioPlex 2200 System.