Singapore HSA registration DE0503827
Bio-Rad Seraclone Anti-k (KEL2)
Singapore·CLASS C IVD·Bio-Rad Medical Diagnostics GmbH·Registered November 19, 2019Device 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 description
Seraclone® Anti-k (KEL2) is used for the determination of the k (Cellano) antigen of red blood cells using the tube test.
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD