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South Korea MFDS registration In vitro water 23-16

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Dong-A Chammed Co., Ltd.·Approved Jan 25, 2023
Basic information
Item Serial Number
2023000404
License Number
In vitro water 23-16
체외수허23-16호
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)
Dong-A Chammed Co., Ltd.
동아참메드 주식회사
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 561 호
Important dates & status
Item Approval Date
Jan 25, 2023
Business Permit Date
May 16, 2005
Expiration Period
2023-01-25 ~ 2028-01-24
Model information
Model Name
LIAISON QuantiFERON-TB Gold Plus
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 water 23-16. Approved on Jan 25, 2023. Registered by Dong-A Chammed Co., Ltd..

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