Abbott Diagnostics Korea Bioline™ Influenza Ultra - HSA Registration DE0506969
Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ Influenza Ultra in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506969 and owned by Abbott Diagnostics Korea Inc.. The device was registered on June 17, 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™ Influenza Ultra is an immunochromatographic assay for the differential and qualitative detection of influenza virus type A and type B antigens directly from nasopharyngeal swab or nasopharyngeal aspirate specimen. The assay is not intended to detect influenza virus type C antigens. The Bioline™ Influenza Ultra is intended for professional use and in vitro diagnostic use only.