Singapore HSA registration DE0503881
Biokit Alinity c β2-Microglobulin
Singapore·CLASS B IVD·Biokit S.A.·Registered December 02, 2019Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0503881
- Registration Date
- December 02, 2019
- Change Notification Approval Date
- September 15, 2023
- Retention Due Date
- December 01, 2025
Product description
The Alinity c β2-Microglobulin reagents are intended for the quantitative determination of β2-microglobulin (β2M) in human serum, plasma, or urine samples using the Alinity c analyzer.
Product Owner
- Name
- Biokit S.A.
- Short Name
- Biokit S.A.
- Address
- Biokit S.A., 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 β2-Microglobulin Assay File Alinity c β2-Microglobulin Standard Alinity c β2-Microglobulin Reagent Kit Alinity c Proteins Control Kit
- Model Identifier(s)
- 01R09-1A 01R0901 01R0920 08P6710
About this record
Access comprehensive regulatory information for Biokit Alinity c β2-Microglobulin 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 DE0503881 and owned by Biokit S.A.. The device was registered on December 02, 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