Beckman Coulter Access Unconjugated Estriol - HSA Registration DE0510472
Access comprehensive regulatory information for Beckman Coulter Access Unconjugated Estriol 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 DE0510472 and owned by Beckman Coulter Inc. The device was registered on March 17, 2025.
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 Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems. The concentration of unconjugated estriol determined by this kit can be used in conjunction with ฮฒhCG, AFP, and Inhibin A concentrations in Trisomy 18 and 21 (Down syndrome) risk assessment. Such an approach has been verified on the basis of multivariate Gaussian distribution analysis.