Exact Diagnostics HIV-1 Controls - HSA Registration DE0509391
Access comprehensive regulatory information for Exact Diagnostics HIV-1 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 DE0509391 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.
The EDX HIV-1 Controls are external quality controls, intended to be used with HIV-1 assays to monitor the performance of that given assay. EDX HIV-1 Controls are calibrated against the 3rd WHO International Standard for HIV (10/152). The EDX HIV-1 Low and High Run Controls are used to monitor the presence of Human Immunodeficiency Virus (HIV-1) RNA. Routine use of EDX HIV-1 Low and High Run Controls allows laboratories to evaluate the day-to-day and lot-to-lot variation of their molecular assay and test for operator proficiency. EDX HIV-1 RNA Screen Control is intended to test the entire process of a variety of blood donor screening assays through extraction, amplification, and detection.