Biokit Alinity c D-Dimer - HSA Registration DE0508249
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.
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.