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Bio-Rad Seraclone Anti-k (KEL2) - HSA Registration DE0503827

Access comprehensive regulatory information for Bio-Rad Seraclone Anti-k (KEL2) 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 DE0503827 and owned by Bio-Rad Medical Diagnostics GmbH. The device was registered on November 19, 2019.

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
DE0503827
Bio-Rad Seraclone Anti-k (KEL2)
HSA Registration Number: DE0503827
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Product Description

Seraclone® Anti-k (KEL2) is used for the determination of the k (Cellano) antigen of red blood cells using the tube test.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0503827
Registration Date
November 19, 2019
Change Notification Approval Date
June 17, 2021
Retention Due Date
November 18, 2025
Product Owner
Short Name
Bio-Rad Medical Diagnostics GmbH
Address
Industriestr. 1, 63303 Dreieich, Deutschland, GERMANY
Registrant
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model Information
Model Name(s)
Seraclone Anti-k (KEL2)
Model Identifier(s)
808126