Singapore HSA registration DE0509660
SD Biosensor STANDARD™ Q Dengue NS1 Ag Test
Singapore·CLASS C IVD·SD Biosensor, Inc.·Registered August 16, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509660
- Registration Date
- August 16, 2024
- Retention Due Date
- August 15, 2025
Product description
STANDARD Q Dengue NS1 Ag Test is an immunochromatographic assay for the detection of NS1 antigens in human serum, plasma, or whole blood samples. This test kit is for use in in-vitro diagnostic procedure.
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 NS1 Ag Test Device
- Model Identifier(s)
- QDEN01G
About this record
Access comprehensive regulatory information for SD Biosensor STANDARD™ Q Dengue NS1 Ag 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 DE0509660 and owned by SD Biosensor, Inc.. The device was registered on August 16, 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