SD Biosensor STANDARD™ F Influenza A/B FIA - HSA Registration DE0510305
Access comprehensive regulatory information for SD Biosensor STANDARD™ F Influenza A/B FIA 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 DE0510305 and owned by SD Biosensor, Inc.. The device was registered on February 05, 2025.
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 STANDARD™ F Influenza A/B FIA is the fluorescence immunoassay to detect influenza infection in human nasal swab and nasopharyngeal swab, wash, or aspirate specimens, identifying existence of influenza type A and B viral nucleoprotein antigens. STANDARD™ F Influenza A/B FIA should be used with the STANDARD™ F Analyzers manufactured by SD BIOSENSOR. This is intended for professional use, only for an initial screening test.