Singapore HSA registration DE0509050
CTK Biotech OnSite Duo Dengue Ag-IgG/IgM Rapid Test
Singapore·CLASS C IVD·CTK Biotech, Inc·Registered March 12, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509050
- Registration Date
- March 12, 2024
- Retention Due Date
- March 11, 2026
Product description
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.
Product Owner
- Name
- CTK Biotech, Inc
- Short Name
- CTK Biotech, Inc
- Address
- 13855 Stowe Dr, Poway, California, 92064, UNITED STATES
Registrant
- Name
- MEDRA+ PTE. LTD.
- Address
- 6 KITCHENER LINK, CITY SQUARE RESIDENCES, #05-11, SINGAPORE 207227
Model information
- Model Name(s)
- OnSite™ Duo Dengue Ag-IgG/IgM Rapid Test Kit OnSite™Duo Dengue Ag-IgG/IgM Rapid Test Kit
- Model Identifier(s)
- R0062C R0062C-10T
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD