Abbott Alinity s Syphilis - HSA Registration DE0506093
Access comprehensive regulatory information for Abbott Alinity s Syphilis in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0506093 and owned by Abbott GmbH. The device was registered on August 20, 2021.
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 Alinity s Syphilis assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to Treponema pallidum (T pallidum, TP) in human serum and plasma, including specimens collected post-mortem (non-heart-beating) on the Alinity s System. The Alinity s Syphilis assay is intended to be used as an aid in the diagnosis of Syphilis infection and as a screening test to prevent transmission of T pallidum to recipients of blood, blood components, cells, tissue and organs.