Singapore HSA registration DE0508323
Diagast Anti-K (PK1) Phenotyping Reagent
Singapore·CLASS D IVD·Diagast·Registered July 25, 2023Device classification
- Device Class
- CLASS D IVD
- Medical Speciality Area
- Hematology
Registration information
- Registration Number
- DE0508323
- Registration Date
- July 25, 2023
- Retention Due Date
- July 24, 2025
Product description
The Anti-K (KEL1) PK1 reagent is used for RH-K phenotyping of human red blood cells. It detects the presence of antigen K on the surface of red blood cells. The reagent is ready for use and can thus be directly used with BECKMAN COULTER terraced microplates on the BECKMAN COULTER PK7400 Automated Microplate System
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-K (PK1) CONTROL PK BROMELINE PK
- Model Identifier(s)
- B10341 B10350 B10351
About this record
Access comprehensive regulatory information for Diagast Anti-K (PK1) Phenotyping Reagent 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 DE0508323 and owned by Diagast. The device was registered on July 25, 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