HSA · registration DE0510323Alba Bioscience Ortho Sera Anti-Lea and Anti-Leb
SingaporeHematologyClass CALBA Bioscience Limited
Official record identity
- Registration number
- DE0510323
- Model name
- ORTHO Sera Anti-Lea; ORTHO Sera Anti-Leb
- Model identifier
- 6904497; 6904498
- Registration date
- February 10, 2025
Classification
- Risk class
- Class C
Official value: CLASS C
Published parties
- Product owner
- ALBA Bioscience Limited
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
Official description
The Anti-Lea reagent is for the qualitative in vitro detection of human Lea positive red blood cells by the direct agglutination test. The Anti-Leb reagent is for the qualitative in vitro detection of human Leb positive red blood cells by the direct agglutination test.
Additional source fields
- Product owner address
- 5 James Hamilton Way, Penicuik, Midlothian, EH26 0BF, 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.