Singapore HSA registration DE0016667
Diagst blood Rh-kell phenotyping test kit
Singapore·CLASS D IVD·Diagast·Registered December 22, 2014Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Hematology
- HSA Product Code
- HSAMDD00106
- HS Code
- 30062000
Registration information
- Registration Number
- DE0016667
- Registration Date
- December 22, 2014
- Change Notification Approval Date
- October 18, 2024
- Retention Due Date
- December 21, 2025
Product description
Designed for analyses of human biological samples. They are used for RH-K phenotyping of human red blood cells. They make it possible to determine the presence of the antigens C (RH2), E (RH3), c (RH4), e (RH5) and K (KEL1) on the red blood cell surface.
Product Owner
- Name
- Diagast
- Short Name
- Diagast
- Address
- 251 avenue Eugene Avinee BP 9, 59374 LOOS CEDEX, FRANCE
Registrant
- Name
- LABOTECH PTE LTD
- Address
- 300 TAMPINES AVENUE 5, INCOME AT TAMPINES JUNCTION, #09-02, SINGAPORE 529653
Importer
- Name
- LABOTECH PTE LTD
- Address
- 239B VICTORIA STREET, SINGAPORE 188029
Model information
- Model Name(s)
- HEMA CQI Anti-c (RH4) Anti-DCE (RH1,2,3) Anti-C (RH2) Anti-E (RH3) Anti-e (RH5) Anti-K (KEL1) PHENOKIT NEG CONTROL
- Model Identifier(s)
- 59500 74011 74111 74221 74311 74611 74711 74911 79000
About this record
Access comprehensive regulatory information for Diagst blood Rh-kell phenotyping test kit in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0016667 and owned by Diagast. The device was registered on December 22, 2014.
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 D IVD