Bio-Rad Access HCV Ab V3 - HSA Registration DE0502692
Access comprehensive regulatory information for Bio-Rad Access HCV Ab V3 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 DE0502692 and owned by Bio-Rad. The device was registered on January 18, 2019.
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 Access HCV Ab V3 is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of antibodies to the hepatitis C virus in human serum or plasma (Lithium heparin, K2-EDTA, K3-EDTA, citrate, CPDA-1 or ACD), using the Access Immunoassay Systems. The Access HCV Ab V3 is intended to be used as an aid in the diagnosis of HCV infection and as a screening test for blood and plasma donors. The assay is not intended for the testing or screening of pooled specimens.