HSA · registration DE0505240Ortho-Clinical Diagnostics Ortho Coombs Control
SingaporeHematologyClass COrtho-Clinical Diagnostics
Official record identity
- Registration number
- DE0505240
- Model name
- Ortho Coombs Control
- Model identifier
- 6901868
- Registration date
- December 11, 2020
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- Ortho-Clinical Diagnostics
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Official description
Qualitative test to confirm the validity of negative antiglobulin tests.
Additional source fields
- Product owner address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
About this record
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.