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Biokit Alinity c Digitoxin - HSA Registration DE0509243

Access comprehensive regulatory information for Biokit Alinity c Digitoxin in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509243 and owned by Biokit S.A.. The device was registered on April 29, 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 C IVD
DE0509243
Biokit Alinity c Digitoxin
HSA Registration Number: DE0509243
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Product Description

The Alinity c Digitoxin assay is used for the quantitative determination of digitoxin in human serum on the Alinity c analyzer.

Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Clinical chemistry
Registration Information
Registration Number
DE0509243
Registration Date
April 29, 2024
Retention Due Date
April 28, 2026
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 Digitoxin Assay File Alinity c Digitoxin Standard Alinity c Digitoxin Controls Alinity c Digitoxin Reagent Kit
Model Identifier(s)
01R11-1A 01R1101 01R1110 01R1122