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Biokit Alinity c A1-Antitrypsin - HSA Registration DE0503928

Access comprehensive regulatory information for Biokit Alinity c A1-Antitrypsin 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 DE0503928 and owned by Biokit S.A.. The device was registered on December 12, 2019.

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
DE0503928
Biokit Alinity c A1-Antitrypsin
HSA Registration Number: DE0503928
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Product Description

The Alinity c A1-Antitrypsin assay is used for the quantitative determination of alpha1-antitrypsin in serum or plasma on the Alinity c analyzer.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0503928
Registration Date
December 12, 2019
Change Notification Approval Date
November 02, 2023
Retention Due Date
December 11, 2025
Product Owner
Short Name
Biokit S.A.
Address
Av. Can Montcau 7, 08186 Lliรงร  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 A1-Antitrypsin Assay File Alinity c A1-Antitrypsin Reagent Kit Alinity c Proteins Standard Alinity c Proteins Control Kit
Model Identifier(s)
01R07-1A 01R0720 08P6701 08P6710