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Diagst blood rare sera phenotyping test kit (Fya (FY1), Fyb (FY2), S (MNS3), s (MNS4)) - HSA Registration DE0016666

Access comprehensive regulatory information for Diagst blood rare sera phenotyping test kit (Fya (FY1), Fyb (FY2), S (MNS3), s (MNS4)) 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 DE0016666 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.

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HSA Official Data
CLASS D IVD
DE0016666
Diagst blood rare sera phenotyping test kit (Fya (FY1), Fyb (FY2), S (MNS3), s (MNS4))
HSA Registration Number: DE0016666
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Product Description

Intended for the analysis of human biological specimens. The reagents are used in the phenotyping of human red blood cells. They determine the presence of antigens Fya (FY1), Fyb (FY2), S (MNS3) and s (MNS4) on the surface of red blood cells.

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Hematology
HSA Product Code
HSAMDD00106
HS Code
30062000
Registration Information
Registration Number
DE0016666
Registration Date
December 22, 2014
Change Notification Approval Date
October 18, 2024
Retention Due Date
December 21, 2025
Product Owner
Short Name
Diagast
Address
251 avenue Eugene Avinee BP 9, 59374 LOOS CEDEX, FRANCE
Registrant
Address
300 TAMPINES AVENUE 5, INCOME AT TAMPINES JUNCTION, #09-02, SINGAPORE 529653
Importer
Address
239B VICTORIA STREET, SINGAPORE 188029
Model Information
Model Name(s)
LISS AGH MAESTRIA C3D AGH MAESTRIA IGG AGH MAESTRIA IGG+C3D Anti-S (MNS3) Anti-s (MNS4) Anti-Fyb (FY2) Anti-Fya (FY1) POLYCONTROL(for polyclonal reagents) NEG CONTROL (for monoclonal reagents)
Model Identifier(s)
69013 76118 76218 76318 78007 78008 78012 78014 78200 79000