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Singapore HSA registration DE0510305

SD Biosensor STANDARD™ F Influenza A/B FIA

Singapore flagSingapore·CLASS B IVD·SD Biosensor, Inc.·Registered February 05, 2025
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
Microbiology
Registration information
Registration Number
DE0510305
Registration Date
February 05, 2025
Retention Due Date
February 04, 2026
Product description
The STANDARD™ F Influenza A/B FIA is the fluorescence immunoassay to detect influenza infection in human nasal swab and nasopharyngeal swab, wash, or aspirate specimens, identifying existence of influenza type A and B viral nucleoprotein antigens. STANDARD™ F Influenza A/B FIA should be used with the STANDARD™ F Analyzers manufactured by SD BIOSENSOR. This is intended for professional use, only for an initial screening test.
Product Owner
Name
SD Biosensor, Inc.
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
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Importer
Name
SPD SCIENTIFIC PTE LTD
Address
100H PASIR PANJANG ROAD, OC@PASIR PANJANG, #07-01, SINGAPORE 118524
Model information
Model Name(s)
STANDARD™ F Influenza A/BControl swab STANDARD™ F Influenza A/B FIA
Model Identifier(s)
C-F-INF-01 FINF01G
About this record

Access comprehensive regulatory information for SD Biosensor STANDARD™ F Influenza A/B FIA in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0510305 and owned by SD Biosensor, Inc.. The device was registered on February 05, 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 B IVD