Diagast Anti-A, Anti-B, Anti-A,B (PK1) Blood Grouping Reagents - HSA Registration DE0510538
Access comprehensive regulatory information for Diagast Anti-A, Anti-B, Anti-A,B (PK1) Blood Grouping Reagents 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 DE0510538 and owned by Diagast. The device was registered on April 02, 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.
Anti-A, Anti-B, Anti-A,B (PK1) are in vitro diagnostic medical devices (IVDMD) intended to be used by healthcare professionals, biologists or lab technicians for the qualitative detection of red blood cell antigens in donor blood samples with anticoagulant (EDTA) using a microplate automated method. The determination of the forward (antigen) typing with the reverse (antibody) typing in donors is intended to ensure immunological compatibility and safe transfusion of blood and blood components.