Singapore HSA registration DE0506734
CTK Biotech OnSite® Dengue IgG Rapid Test
Singapore·CLASS C IVD·CTK Biotech, Inc·Registered March 21, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506734
- Registration Date
- March 21, 2022
- Retention Due Date
- March 20, 2026
Product description
The OnSite® Dengue IgG Rapid Test is a lateral flow immunoassay for the qualitative detection of anti-dengue virus IgG antibodies against the four dengue serotypes (DENV1, 2, 3, 4) in human whole blood, serum or plasma specimens. It is intended to be used by healthcare professionals to determine dengue serostatus as an indication of past exposure to dengue virus. In conjunction with medical history and epidemiological information, the OnSite® Dengue IgG Rapid Test is designed to guide healthcare providers on patient counseling and management, including for prevaccination screening.
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
Importer
- Address
- 1 SHENTON WAY, ONE SHENTON, #35-05, SINGAPORE 068803
Model information
- Model Name(s)
- Onsite® Dengue IgG Rapid Test
- Model Identifier(s)
- R0065C
About this record
Access comprehensive regulatory information for CTK Biotech OnSite® Dengue IgG 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 DE0506734 and owned by CTK Biotech, Inc. The device was registered on March 21, 2022.
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD