Singapore HSA registration DE0016666
Diagst blood rare sera phenotyping test kit (Fya (FY1), Fyb (FY2), S (MNS3), s (MNS4))
Singapore·CLASS D IVD·Diagast·Registered December 22, 2014Device 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 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.
Product Owner
- Name
- Diagast
- Short Name
- Diagast
- Address
- 251 avenue Eugene Avinee BP 9, 59374 LOOS CEDEX, FRANCE
Registrant
- Name
- LABOTECH PTE LTD
- Address
- 300 TAMPINES AVENUE 5, INCOME AT TAMPINES JUNCTION, #09-02, SINGAPORE 529653
Importer
- Name
- LABOTECH PTE LTD
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D IVD