HSA · registration DE0510211Immucor immuClone Anti-H IgM
- Registration number
- DE0510211
- Model name
- immuClone® Anti-H IgM
- Model identifier
- 0009525
- Registration date
- January 06, 2025
- Risk class
- Class C
- Product owner
- Immucor Medizinische Diagnostik GmbH
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
immuClone® Anti-H IgM is an in vitro diagnostic Blood Grouping Reagent used to detect the H blood group antigens on human red blood cells from donors and recipients by indirect hemagglutination test for the purpose of a blood transfusion to ensure the safety and compatibility between the patient and the blood component selected for transfusion. immuClone® Anti-H IgM is intended for Manual Saline Tube Tests (qualitative).
- Product owner address
- Robert-Bosch-Strasse 32, DREIEICH, 63303, Germany, Germany
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
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.