Singapore HSA registration DE0503626
Bio-Rad Seraclone Anti-Lea (LE1) and Leb (LE2)
Singapore·CLASS C IVD·Bio-Rad Medical Diagnostics GmbH·Registered September 23, 2019Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0503626
- Registration Date
- September 23, 2019
- Change Notification Approval Date
- June 17, 2021
- Retention Due Date
- September 22, 2025
Product description
It is used for the determination of the Lea and Leb 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-Lea (LE1) Seraclone Anti-Leb (LE2)
- Model Identifier(s)
- 808404 808423
About this record
Access comprehensive regulatory information for Bio-Rad Seraclone Anti-Lea (LE1) and Leb (LE2) 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 DE0503626 and owned by Bio-Rad Medical Diagnostics GmbH. The device was registered on September 23, 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