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Diagast Extended Typing Reagents ANTI-Jka PK and ANTI-Jkb PK - HSA Registration DE0507915

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.

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CLASS D IVD
DE0507915
Diagast Extended Typing Reagents ANTI-Jka PK and ANTI-Jkb PK
HSA Registration Number: DE0507915
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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.

Device 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 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-Jka (JK1) PK ANTI-Jkb (JK2) PK NEG CONTROL PK LISS PK
Model Identifier(s)
73022 73023 73026 73029