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Biokit Alinity c IgE - HSA Registration DE0506950

Access comprehensive regulatory information for Biokit Alinity c IgE 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 DE0506950 and owned by Biokit S.A.. The device was registered on June 14, 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.

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CLASS B IVD
DE0506950
Biokit Alinity c IgE
HSA Registration Number: DE0506950
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Product Description

The Alinity c IgE assay is used for the quantitative determination of immunoglobulin E (IgE) in human serum or plasma on the Alinity c system.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0506950
Registration Date
June 14, 2022
Retention Due Date
June 13, 2025
Product Owner
Short Name
Biokit S.A.
Address
Av. Can Montcau 7, 08186 Llica d'Amunt, Barcelona, SPAIN
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
Alinity c IgE Assay File Alinity c IgE Standard Alinity c IgE Alinity c Ferritin/Myoglobin/IgE Control Kit
Model Identifier(s)
01R13-1A 01R1301 01R1322 04R4616