Sebia HYDRASHIFT 2/4 isatuximab - HSA Registration DE0507240
Access comprehensive regulatory information for Sebia HYDRASHIFT 2/4 isatuximab 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 DE0507240 and owned by SEBIA. The device was registered on September 06, 2022.
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 HYDRASHIFT 2/4 isatuximab (40 tests) kit is to be used in conjunction with the HYDRAGEL IF kits and the semi-automated HYDRASYS 2 electrophoresis apparatus. The HYDRASHIFT 2/4 isatuximab (40 tests) kit with the HYDRAGEL IF kit is intended for the qualitative detection of monoclonal proteins in human serum by immunofixation electrophoresis. The electrophoregrams are evaluated visually for the presence of specific reactions with the suspect monoclonal proteins. The HYDRASHIFT 2/4 isatuximab (40 tests) kit removes the isatuximab Ig G, Kappa interference and enables the visual evaluation of the presence or absence of monoclonal proteins on the HYDRAGEL IF kits in patients who have received isatuximab therapy. This device is intended for professional use only. For In Vitro Diagnostic Use only.