Sebia FLC Kappa and FLC Lambda - HSA Registration DE0509291
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.
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.