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South Korea MFDS registration In Vitro Drug No. 23-1089

Genetic testing reagent for high-risk infections

KO: 고위험성감염체유전자검사시약
South Korea flagSouth Korea·Unknown·SDBiosensor Co., Ltd.·Approved Nov 27, 2023
Basic information
Item Serial Number
2023006676
License Number
In Vitro Drug No. 23-1089
체외제허23-1089호
Classification Number
N05030.01
Device Class (Risk Classification)
Unknown
Classification Name
Genetic testing reagent for high-risk infections
고위험성감염체유전자검사시약
Official English Name
IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than 'high risk pathogens', Infectious agents with moderate infectivity), molecular diagnostics
Company information
Entity Name (Company)
SDBiosensor Co., Ltd.
에스디바이오센서(주)
Category
In Vitro Diagnostic Manufacturing
체외진단제조업
Business License Number
체외 제 4413 호
Important dates & status
Item Approval Date
Nov 27, 2023
Business Permit Date
Jan 10, 2014
Model information
Model Name
STANDARD™ M10 STI Panel (M10-STI-01)
About this record

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Drug No. 23-1089. Approved on Nov 27, 2023. Registered by SDBiosensor Co., Ltd..

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