Singapore HSA registration DE0510323
Alba Bioscience Ortho Sera Anti-Lea and Anti-Leb
Singapore·CLASS C IVD·ALBA Bioscience Limited·Registered February 10, 2025Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0510323
- Registration Date
- February 10, 2025
- Retention Due Date
- February 09, 2026
Product 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.
Product Owner
- Short Name
- ALBA Bioscience Limited
- Address
- 5 James Hamilton Way, Penicuik, Midlothian, EH26 0BF, UNITED KINGDOM
Registrant
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Importer
- Address
- 1 INTERNATIONAL BUSINESS PARK, THE SYNERGY, #01-12, SINGAPORE 609917
Model information
- Model Name(s)
- ORTHO Sera Anti-Lea ORTHO Sera Anti-Leb
- Model Identifier(s)
- 6904497 6904498
About this record
Access comprehensive regulatory information for Alba Bioscience Ortho Sera Anti-Lea and Anti-Leb 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 DE0510323 and owned by ALBA Bioscience Limited. The device was registered on February 10, 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