Technoclone TECHNOZYM® ADAMTS-13 Antigen - HSA Registration DE0504395
Access comprehensive regulatory information for Technoclone TECHNOZYM® ADAMTS-13 Antigen 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 DE0504395 and owned by Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH. The device was registered on April 27, 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 TECHNOZYM® ADAMTS-13 Antigen ELISA is a chromogenic test for the determination of ADAMTS-13 antigen concentration in human plasma. ADAMTS-13 is the enzyme that cleaves vWF under laminar flow conditions. A functional defect of this enzyme leads to the presence of higher molecular weight forms of vWF and thus to increased platelet aggregation, mainly in the microvasculature. This is believed to be the major cause for thrombotic thrombocytopenic Purpura (TTP).