Pure Global

SEBIA CAPI 3 PROTEIN(E) 6 - HSA Registration DE0505230

Access comprehensive regulatory information for SEBIA CAPI 3 PROTEIN(E) 6 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 DE0505230 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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B IVD
DE0505230
SEBIA CAPI 3 PROTEIN(E) 6
HSA Registration Number: DE0505230
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The CAPI 3 PROTEIN(E) 6 kit is designed for the separation of human serum proteins by capillary electrophoresis in alkaline buffer (pH 9.9) with the CAPILLARYS 3 instrument. Normal serum proteins separate into six major fractions. The CAPILLARYS 3 instrument performs all sequences automatically to obtain a protein profile for qualitative or quantitative analysis. The proteins, separated in silica capillaries, are directly detected at an absorbance of 200 nm. The electrophoregrams can be interpreted visually to screen for any pattern abnormalities. Direct detection provides accurate relative quantification of individual protein fractions. For In Vitro Diagnostic Use.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0505230
Registration Date
December 09, 2020
Retention Due Date
December 08, 2025
Product Owner
Name
SEBIA
Short Name
SEBIA
Address
Parc Technologique, Lรฉonard de Vinci, CP 8010 โ€“ 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)
CAPILLARYS 3 OCTA CAPILLARYS 3 TERA CAPI 3 PROTEIN(E) 6 NORMAL CONTROL (5) NORMAL CONTROL (20)
Model Identifier(s)
1245 1246 2503 4785 4786