Singapore HSA registration DE0509291
Sebia FLC Kappa and FLC Lambda
Singapore·CLASS C IVD·SEBIA·Registered May 15, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509291
- Registration Date
- May 15, 2024
- Retention Due Date
- May 14, 2025
Product description
The FLC Kappa and FLC Lambda kits are intended for the quantification of Kappa and Lambda free light chains in human serum from adults with an Enzyme- Linked Immunosorbent Assay (ELISA) manual procedure. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma and AL amyloidosis. It must be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use only.
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)
- FLC Kappa FLC Lambda FLC CONTROL LEVEL 1 FLC CONTROL LEVEL 2
- Model Identifier(s)
- 5102 5103 5112 5113
About this record
Access comprehensive regulatory information for Sebia FLC Kappa and FLC Lambda in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509291 and owned by SEBIA. The device was registered on May 15, 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 C IVD