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South Korea MFDS registration In Vitro Drug No. 24-19

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·SDBiosensor Co., Ltd.·Approved Jan 09, 2024
Basic information
Item Serial Number
2024000113
License Number
In Vitro Drug No. 24-19
체외제허24-19호
Classification Number
K05030.01
Device Class (Risk Classification)
Unknown
Classification Name
High-risk infection immunoassay reagent
고위험성감염체면역검사시약
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), immunological method
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
Jan 09, 2024
Business Permit Date
Jan 10, 2014
Expiration Period
2024-01-09 ~ 2029-01-08
Model information
Model Name
STANDARD™ Q COVID/Flu Ag Combo Test (Q-CVFL-01C)
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. 24-19. Approved on Jan 09, 2024. Registered by SDBiosensor Co., Ltd..

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