Abbott Alinity i Galectin-3 - HSA Registration DE0504345
Access comprehensive regulatory information for Abbott Alinity i Galectin-3 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 DE0504345 and owned by Abbott GmbH. The device was registered on April 08, 2020.
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 Alinity i Galectin-3 assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of galectin-3 in human serum and EDTA plasma on the Alinity i analyzer. The Alinity i Galectin-3 assay is to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure (HF).