Singapore HSA registration DE0503926
Biokit Alinity c Lp(a)
Singapore·CLASS B IVD·Biokit S.A.·Registered December 12, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0503926
- Registration Date
- December 12, 2019
- Retention Due Date
- December 11, 2025
Product description
The Alinity c Lp(a) assay is used for the quantitative determination of lipoprotein(a) in human serum or plasma on the Alinity c analyzer.
Product Owner
- Name
- Biokit S.A.
- Short Name
- Biokit S.A.
- Address
- Av. Can Montcau, 7, 08186 Lliçà 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 Lp(a) Assay File Alinity c Lp(a) Calibrators Alinity c Lp(a) Control Kit Alinity c Lp(a) Reagent Kit
- Model Identifier(s)
- 01R14-1A 01R1401 01R1410 01R1420
About this record
Access comprehensive regulatory information for Biokit Alinity c Lp(a) 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 DE0503926 and owned by Biokit S.A.. The device was registered on December 12, 2019.
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