Exact HBV Controls - HSA Registration DE0509390
Access comprehensive regulatory information for Exact HBV Controls 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 DE0509390 and owned by Exact Diagnostics. The device was registered on June 13, 2024.
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.
Exact HBV High and Low Run Controls are external quality controls, intended to be used with HBV assays to monitor the performance of that given assay. Exact HBV High and Low Run Controls are calibrated against the 3rd WHO International Standard for Hepatitis B (10/264). The controls are used to monitor the presence of Hepatitis B Virus (HBV) DNA. Routine use of Exact HBV Low and High Run Controls allow laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency.