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Alba Bioscience Ortho Sera Anti-Lea and Anti-Leb - HSA Registration DE0510323

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.

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CLASS C IVD
DE0510323
Alba Bioscience Ortho Sera Anti-Lea and Anti-Leb
HSA Registration Number: DE0510323
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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.

Device 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 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