Bio- Rad Anti-Human-Globulin Color
- Registration number
- DE0510427
- Model name
- Anti-Human Globulin Color; Anti-Human Globulin Color; Anti-Human Globulin Color; Coombscell-E
- Model identifier
- 804115; 804120; 804130; 816030
- Registration date
- March 06, 2025
- Risk class
- Class C
- Product owner
- Bio-Rad Medical Diagnostics GmbH
- Registrant / registration holder
- BIO-RAD LABORATORIES (SINGAPORE) PTE LTD
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 address
- Industriestr. 1,, 63303 Dreieich, Germany
- Registrant address
- 3A INTERNATIONAL BUSINESS PARK, #11-10/16, ICON@IBP, Singapore 609935
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.