Singapore HSA registration DE0510019
SEBIA HYPERGAMMA CONTROL SERUM
Singapore·CLASS B IVD·SEBIA·Registered November 07, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0510019
- Registration Date
- November 07, 2024
- Retention Due Date
- November 06, 2025
Product description
The serum is designed for the quality control of electrophoretic quantification of human serum proteins on HYDRAGEL and CAPILLARYS & MINICAP. The values obtained must fall within the mean ± 2 SD confidence range provided with each batch of control serum.
Product Owner
- Name
- SEBIA
- Short Name
- SEBIA
- Address
- Parc Technologique, Léonard de Vinci, CP 8010 Lisses, 91008 EVRY Cedex, FRANCE
Registrant
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
- Address
- 51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Model information
- Model Name(s)
- HYPERGAMMA CONTROL SERUM (20) HYPERGAMMA CONTROL SERUM (5)
- Model Identifier(s)
- 4766 4787
About this record
Access comprehensive regulatory information for SEBIA HYPERGAMMA CONTROL SERUM 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 DE0510019 and owned by SEBIA. The device was registered on November 07, 2024.
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