ORGENTEC Diagnostika Anti-Phospholipid IgG/IgM kits - HSA Registration DE0015903
Access comprehensive regulatory information for ORGENTEC Diagnostika Anti-Phospholipid IgG/IgM kits 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 DE0015903 and owned by ORGENTEC Diagnostika GmbH. The device was registered on July 09, 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.
Quantitative enzyme immunoassay (EIA) intended to screen for the presence of IgG and IgM class autoantibodies against cardiolipin, phosphatidyl serine, phosphatidyl inositol, phosphatidic acid and beta-2-glycoprotein I in human serum or plasma as an aid in the diagnosis of an increased risk of thrombosis in patients with systemic lupus erythematosus (SLE) or lupus-like disorders.