Singapore HSA registration DE0506950
Biokit Alinity c IgE
Singapore·CLASS B IVD·Biokit S.A.·Registered June 14, 2022Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0506950
- Registration Date
- June 14, 2022
- Retention Due Date
- June 13, 2025
Product description
The Alinity c IgE assay is used for the quantitative determination of immunoglobulin E (IgE) in human serum or plasma on the Alinity c system.
Product Owner
- Name
- Biokit S.A.
- Short Name
- Biokit S.A.
- Address
- Av. Can Montcau 7, 08186 Llica d'Amunt, Barcelona, SPAIN
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- Alinity c IgE Assay File Alinity c IgE Standard Alinity c IgE Alinity c Ferritin/Myoglobin/IgE Control Kit
- Model Identifier(s)
- 01R13-1A 01R1301 01R1322 04R4616
About this record
Access comprehensive regulatory information for Biokit Alinity c IgE in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506950 and owned by Biokit S.A.. The device was registered on June 14, 2022.
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 B IVD