Bio-Rad Genie Fast HIV 1/2 - HSA Registration DE0015557
Access comprehensive regulatory information for Bio-Rad Genie Fast HIV 1/2 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 DE0015557 and owned by Bio-Rad France. The device was registered on May 23, 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.
The fast test device uses the Immunochromatography (ICT or lateral migration) technique to detect anti-HIV-1 and anti-HIV-2 antibodies in human serum, plasma, venous blood and capillary blood. This kit is not intended for blood donor screening. Any sample found to be reproducibly positive must be confirmed using an appropriate method (Western-Blot or equivalent) to prove the presence of anti-HIV antibodies.