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Singapore HSA registration DE0508249

Biokit Alinity c D-Dimer

Singapore flagSingapore·CLASS B IVD·Biokit S.A.·Registered June 28, 2023
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Clinical chemistry
Registration information
Registration Number
DE0508249
Registration Date
June 28, 2023
Retention Due Date
June 27, 2025
Product description
The D-Dimer assay is used for the quantitative determination of D-Dimer in human citrated plasma on the Alinity c system. The D-Dimer assay is to be used as an aid for diagnosing thrombosis and monitoring thrombolytic therapy. Elevated levels of D-Dimer are found in clinical conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE), and disseminated intravascular coagulation (DIC). D-Dimer levels also rise during the normal pregnancy, but very high levels are associated with complications.
Product Owner
Name
Biokit S.A.
Short Name
Biokit S.A.
Address
Av. Can Montcau, 7, 08186 Lliçà d’Amunt, Barcelona, SPAIN
Registrant
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Name
ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
Model Name(s)
Alinity c D-Dimer Assay File Alinity c D-Dimer Calibrator Alinity c D-Dimer Controls Alinity c D-Dimer
Model Identifier(s)
01R10-1A 01R1001 01R1010 01R1022
About this record

Access comprehensive regulatory information for Biokit Alinity c D-Dimer 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 DE0508249 and owned by Biokit S.A.. The device was registered on June 28, 2023.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD