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Diagast Anti-K (PK1) Phenotyping Reagent - HSA Registration DE0508323

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.

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CLASS D IVD
DE0508323
Diagast Anti-K (PK1) Phenotyping Reagent
HSA Registration Number: DE0508323
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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

Device 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 Owner
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