Singapore HSA registration DE0510390

SD Biosensor STANDARD™ Q COVID/Flu Ag Combo

Singapore flagSingapore·CLASS D IVD·SD Biosensor, Inc.·Registered February 26, 2025
Device classification
Device Class
CLASS D IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0510390
Registration Date
February 26, 2025
Retention Due Date
February 25, 2026
Product description
The STANDARD Q COVID/Flu Ag Combo Test is a rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2 and Influenza A and Influenza B present in human nasopharyngeal specimens. The STANDARD Q COVID/Flu Ag Combo Test for rapid detection of SARS-CoV-2, Influenza A and Influenza B is a differentiated test, such that SARS-CoV-2 viral antigens can be distinguished from Influenza A or Influenza B viral antigens from a single specimen using a single device. This test is for administration by healthcare workers and labs only, as an aid to early diagnosis of SARS-CoV-2, Influenza A or Influenza B infection in patient with clinical symptoms with viral infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2, Influenza A or Influenza B infection.
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™COVID/Flu Ag Control Swab STANDARD™ Q COVID/Flu Ag Combo Test
Model Identifier(s)
C-CVFL-01C Q-CVFL-01C
About this record

Access comprehensive regulatory information for SD Biosensor STANDARD™ Q COVID/Flu Ag Combo in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0510390 and owned by SD Biosensor, Inc.. The device was registered on February 26, 2025.

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 D IVD