Siemens ADVIA Chemistry 1800, 2400, XPT Rheumatoid Factor (RF) - HSA Registration DE0011450
Access comprehensive regulatory information for Siemens ADVIA Chemistry 1800, 2400, XPT Rheumatoid Factor (RF) 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 DE0011450 and owned by Simens Healthcare Diagnostics Inc.. The device was registered on October 24, 2012.
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 IVD System is for in vitro diagnostic use in the quantitative determination of rheumatoid factor in human serum on the ADVIA Chemistry systems. Such measurements are used in the diagnosis of rheumatoid arthritis. Rheumatoid factors are auto-antibodies directed against the Fc portion of IgG. The majority of rheumatoid factors are IgM, but may be IgG or IgA. Conditions giving rise to such factors include rheumatic conditions and chronic inflammatory processes.