Singapore HSA registration DE0510427
Bio- Rad Anti-Human-Globulin Color
Singapore·CLASS C IVD·Bio-Rad Medical Diagnostics GmbH·Registered March 06, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510427
- Registration Date
- March 06, 2025
- Retention Due Date
- March 05, 2026
Product description
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.
Product Owner
- Short Name
- Bio-Rad Medical Diagnostics GmbH
- Address
- Industriestr. 1,, 63303 Dreieich, GERMANY
Registrant
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
- Address
- 3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model information
- Model Name(s)
- Anti-Human Globulin Color Anti-Human Globulin Color Anti-Human Globulin Color Coombscell-E
- Model Identifier(s)
- 804115 804120 804130 816030
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD