Singapore HSA registration DE0506938
Abbott Diagnostics Korea Bioline™ Dengue IgG/IgM WB
Singapore·CLASS C IVD·Abbott Diagnostics Korea Inc.·Registered June 06, 2022Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0506938
- Registration Date
- June 06, 2022
- Retention Due Date
- June 05, 2025
Product description
Bioline™ Dengue IgG/IgM WB test device is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to dengue virus in human serum, plasma or whole blood. This test is intended for professional use to aid in the presumptive diagnosis between primary and secondary dengue infection. This test provides only a preliminary test result. Therefore, isolation of virus, antigen detection in fixed tissues, RT-PCR and serological test like haemagglutination-inhibition test, more specific alternative diagnosis method must be used in order to obtain a confirmation of dengue virus infection.
Product Owner
- Short Name
- Abbott Diagnostics Korea Inc.
- Address
- 65, Borahagal-ro, Giheung-gu,, Yongin-si, Gyeonggi-do 17099, KOREA, REPUBLIC OF
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model information
- Model Name(s)
- Bioline Dengue IgG/IgM WB
- Model Identifier(s)
- 11FK20
About this record
Access comprehensive regulatory information for Abbott Diagnostics Korea Bioline™ Dengue IgG/IgM WB 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 DE0506938 and owned by Abbott Diagnostics Korea Inc.. The device was registered on June 06, 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