Singapore HSA registration DE0509620
SD Biosensor STANDARD™ Q Dengue IgM/IgG Test
Singapore·CLASS C IVD·SD Biosensor, Inc.·Registered August 05, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509620
- Registration Date
- August 05, 2024
- Retention Due Date
- August 04, 2025
Product description
STANDARD Q Dengue IgM/IgG Test is an immunochromatographic assay for the detection of IgM/IgG antibodies to dengue in human serum, plasma, or whole blood specimens. This test kit is for use in in-vitro diagnostics and for professional use.
Product Owner
- Short Name
- SD Biosensor, Inc.
- Address
- C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, KOREA, REPUBLIC OF
Registrant
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
- Address
- 100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
- Model Name(s)
- STANDARD™ Q Dengue IgM/IgG Test Device
- Model Identifier(s)
- QDEN01B
About this record
Access comprehensive regulatory information for SD Biosensor STANDARD™ Q Dengue IgM/IgG 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 DE0509620 and owned by SD Biosensor, Inc.. The device was registered on August 05, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD