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Singapore HSA registration DE0505231

SEBIA CAPI 3 IMMUNOTYPING

Singapore flagSingapore·CLASS B IVD·SEBIA·Registered December 09, 2020
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0505231
Registration Date
December 09, 2020
Retention Due Date
December 08, 2025
Product description
The CAPI 3 IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS 3 instrument, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPI 3 PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9). The CAPILLARYS 3 instrument performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively. The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm. The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. For In Vitro Diagnostic Use.
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)
CAPILLARYS 3 OCTA CAPILLARYS 3 TERA CAPI 3 IMMUNOTYPING IT/IF CONTROL
Model Identifier(s)
1245 1246 2600 4788
About this record

Access comprehensive regulatory information for SEBIA CAPI 3 IMMUNOTYPING 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 DE0505231 and owned by SEBIA. The device was registered on December 09, 2020.

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