Technoclone TECHNOZYM® ADAMTS-13 INH - HSA Registration DE0504396
Access comprehensive regulatory information for Technoclone TECHNOZYM® ADAMTS-13 INH 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 DE0504396 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 INH ELISA is a test for detection of human autoantibodies (IgG) in serum or plasma against ADAMTS-13, the protease which is responsible for cleaving unusually large vWF (ULvWF). Most of these autoantibodies inhibit ADAMTS-13 activity and thus non-cleaved ULvWF accumulates in plasma. This is believed to be the major cause for thrombotic thrombocytopenic purpura (TTP). TECHNOZYM® ADAMTS-13 INH test makes it possible to differentiate between congenital (gene polymorphisms) and acquired (autoantibodies) TTP when coupled to an activity assay and to control efficacy of plasma exchange therapy.