Singapore HSA registration DE0507915
Diagast Extended Typing Reagents ANTI-Jka PK and ANTI-Jkb PK
Singapore·CLASS D IVD·Diagast·Registered March 17, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0507915
- Registration Date
- March 17, 2023
- Retention Due Date
- March 16, 2026
Product description
The reagents ANTI-Jka (JK1) PK, ANTI-Jkb (JK2) PK are used for the extended phenotyping of human red blood cells. They detect the presence of Jka, Jkb antigens on the surface of red blood cells. These reagents are ready to use and can thus be directly used with BECKMAN COULTER terraced microplates on the BECKMAN COULTER PK7300 and PK7400 Automated Microplate Systems.
Product Owner
- Name
- Diagast
- Short Name
- Diagast
- Address
- 251 avenue Eugene Avinee, Eurasante Parc, 59120 LOOS FRANCE, FRANCE
Registrant
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Importer
- Address
- 70 BENDEMEER ROAD, LUZERNE, #03-04, SINGAPORE 339940
Model information
- Model Name(s)
- ANTI-Jka (JK1) PK ANTI-Jkb (JK2) PK NEG CONTROL PK LISS PK
- Model Identifier(s)
- 73022 73023 73026 73029
About this record
Access comprehensive regulatory information for Diagast Extended Typing Reagents ANTI-Jka PK and ANTI-Jkb PK 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 DE0507915 and owned by Diagast. The device was registered on March 17, 2023.
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