Singapore HSA registration DE0016664
Diagst blood ABO-D typing test kit
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
- DE0016664
- Registration Date
- December 22, 2014
- Change Notification Approval Date
- October 18, 2024
- Retention Due Date
- December 21, 2025
Product description
Intended for the red blood cell determination of blood ABO group. They enable determination of the presence of erythrocytic antigens A and/or B on the surface of human red blood cells. The ANTI-D (RH1) IgM I, ANTI-D (RH1) IgM II, ANTI-D (RH1) TOTEM and ANTI-D (RH1) IgG are used for blood grouping. They enable the determination of the presence of antigen D (RH1) on the surface of human red blood cells. ANTI-DCE (RH1,2,3) enable detection of the presence of at least one of erythrocytic antigens: D (RH1), C (RH2) and E (RH3).
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)
- HEMA CQI Anti-A (ABO1) Anti-B (ABO1) Anti-A, B (ABO3) GROUPAKIT Anti-D (RH1) IgM I Anti-D (RH1) IgM II Anti-D (RH1) Totem Anti-D (RH1) IgG AGH MAESTRIA C3D AGH MAESTRIA IGG AGH MAESTRIA IGG+C3D NEG CONTROL
- Model Identifier(s)
- 59500 70501 70502 70503 70888 71000 71005 71010 71020 76118 76218 76318 79000
About this record
Access comprehensive regulatory information for Diagst blood ABO-D typing test kit 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 DE0016664 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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