Technoclone TECHNOZYM® ADAMTS-13 Activity ELISA - HSA Registration DE0504398
Access comprehensive regulatory information for Technoclone TECHNOZYM® ADAMTS-13 Activity ELISA 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 DE0504398 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 Activity ELISA is a quantitative test for aid in the diagnosis of TTP, using venous-drawn fresh and/or frozen human citrated (3.2% sodium citrate) platelet poor plasma, only when considered in conjunction with other clinical indicators. The assay is performed on microplate readers capable of reading a wavelength of 450 nm. The TECHNOZYM® ADAMTS-13 Activity ELISA is a chromogenic test for measurement of ADAMTS-13 activity. ADAMTS-13 activity measurement serves as an aid in the diagnosis of TTP. The TECHNOZYM® ADAMTS-13 Activity ELISA is intended for prescription use in laboratories by professionals qualified to perform ELISA-based assays.