ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM - HSA Registration DE0015965
Access comprehensive regulatory information for ORGENTEC Diagnostika Alegria Anti-Annexin V IgG/IgM 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 DE0015965 and owned by ORGENTEC Diagnostika GmbH. The device was registered on July 14, 2014.
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.
Anti-Annexin V IgG/IgM is an indirect solid phase enzyme immunoassay (ELISA) for the quantitative measurement of IgG and IgM class autoantibodies against Annexin V in human serum or plasma. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of an increased risk of thrombosis and recurrent fetal loss.