CTK Biotech OnSite Duo Dengue Ag-IgG/IgM Rapid Test - HSA Registration DE0509050
Access comprehensive regulatory information for CTK Biotech OnSite Duo Dengue Ag-IgG/IgM Rapid Test 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 DE0509050 and owned by CTK Biotech, Inc. The device was registered on March 12, 2024.
This page provides complete registration details including product owner information, registrant details, 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 OnSite Duo Dengue Ag-IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-dengue virus IgG, IgM and dengue NS1 antigen (DEN1, 2, 3, 4) in human serum, plasma or whole blood. It is intended to be used by healthcare professionals to aid in the diagnosis of infection with dengue virus. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.