Abbott Diagnostics Korea Bioline™ HIV 1/2 3.0 - HSA Registration DE0506960
Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ HIV 1/2 3.0 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 DE0506960 and owned by Abbott Diagnostics Korea Inc.. The device was registered on June 15, 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.
The Bioline™ HIV 1/2 3.0 is a rapid, qualitative test for the detection of antibodies to all isotypes(IgG, IgM, IgA) specific to HIV-1 including subtypes-O and HIV-2 simultaneously in human serum, plasma or whole blood. The Bioline™ HIV 1/2 3.0 is intended only for professional use, only for an initial screening test and reactive samples should be confirmed by a supplemental assay such as ELISA or Western Blot test.