Pure Global
Singapore HSA registration DE0507240

Sebia HYDRASHIFT 2/4 isatuximab

Singapore flagSingapore·CLASS B IVD·SEBIA·Registered September 06, 2022
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0507240
Registration Date
September 06, 2022
Retention Due Date
September 05, 2025
Product description
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.
Product Owner
Name
SEBIA
Short Name
SEBIA
Address
Parc Technologique, Léonard de Vinci, CP 8010 Lisses, 91008 EVRY Cedex, FRANCE
Registrant
Name
SEBIA SINGAPORE PTE LTD
Address
51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Importer
Name
SEBIA SINGAPORE PTE LTD
Address
51 CHANGI BUSINESS PARK CENTRAL 2, THE SIGNATURE, #09-12, SINGAPORE 486066
Model information
Model Name(s)
HYDRASHIFT 2/4 isatuximab (40 tests) isatuximab CONTROL
Model Identifier(s)
4642 4764
About this record

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD