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SD Biosensor STANDARD™ Q Dengue IgM/IgG Test - HSA Registration DE0509620

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.

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CLASS C IVD
DE0509620
SD Biosensor STANDARD™ Q Dengue IgM/IgG Test
HSA Registration Number: DE0509620
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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.

Device 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 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