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SEBIA HYPERGAMMA CONTROL SERUM - HSA Registration DE0510019

Access comprehensive regulatory information for SEBIA HYPERGAMMA CONTROL SERUM 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 DE0510019 and owned by SEBIA. The device was registered on November 07, 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.

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CLASS B IVD
DE0510019
SEBIA HYPERGAMMA CONTROL SERUM
HSA Registration Number: DE0510019
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Product Description

The serum is designed for the quality control of electrophoretic quantification of human serum proteins on HYDRAGEL and CAPILLARYS & MINICAP. The values obtained must fall within the mean ± 2 SD confidence range provided with each batch of control serum.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0510019
Registration Date
November 07, 2024
Retention Due Date
November 06, 2025
Product Owner
Name
SEBIA
Short Name
SEBIA
Address
Parc Technologique, Léonard de Vinci, CP 8010 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)
HYPERGAMMA CONTROL SERUM (20) HYPERGAMMA CONTROL SERUM (5)
Model Identifier(s)
4766 4787