Bio- Rad Anti-Human-Globulin Color - HSA Registration DE0510427
Access comprehensive regulatory information for Bio- Rad Anti-Human-Globulin Color in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0510427 and owned by Bio-Rad Medical Diagnostics GmbH. The device was registered on March 06, 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.
Polyspecific anti-human-globulins are used for the direct antiglobulin-test to demonstrate the in-vivo coating of red blood cells with antibody molecules and/or complement components (such as autoantibodies, maternal antibodies in Morbus haemolyticus neonatorum, alloantibodies against red cells in transfusion reactions). The indirect antiglobulin-test is used to demonstrate the in-vitro coating of red blood cells with antibody molecules and/or complement components as in antibody detection, antibody identification as well as compatibility tests. Furthermore, blood group antigen typing (with the corresponding test reagent for the indirect antiglobulin-test) can be carried out in the tube test.