Bio-Rad Bioplex 2200 ToRC IgM - HSA Registration DE0506197
Access comprehensive regulatory information for Bio-Rad Bioplex 2200 ToRC IgM in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506197 and owned by Bio-Rad Laboratories, Inc.. The device was registered on September 22, 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 BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and potassium EDTA or heparinized plasma. The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child-bearing age.