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SD Biosensor STANDARD™ Q Dengue NS1 Ag Test - HSA Registration DE0509660

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.

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CLASS C IVD
DE0509660
SD Biosensor STANDARD™ Q Dengue NS1 Ag Test
HSA Registration Number: DE0509660
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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.

Device 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 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