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Biokit Alinity c Lp(a) - HSA Registration DE0503926

Access comprehensive regulatory information for Biokit Alinity c Lp(a) 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 DE0503926 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
DE0503926
Biokit Alinity c Lp(a)
HSA Registration Number: DE0503926
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Product Description

The Alinity c Lp(a) assay is used for the quantitative determination of lipoprotein(a) in human serum or plasma on the Alinity c analyzer.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0503926
Registration Date
December 12, 2019
Retention Due Date
December 11, 2025
Product Owner
Short Name
Biokit S.A.
Address
Av. Can Montcau, 7, 08186 Lliçà 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 Lp(a) Assay File Alinity c Lp(a) Calibrators Alinity c Lp(a) Control Kit Alinity c Lp(a) Reagent Kit
Model Identifier(s)
01R14-1A 01R1401 01R1410 01R1420