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South Korea MFDS registration In Vitro Water Permit No. 23-231

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Siemens Healthineers Co., Ltd.·Approved Jun 08, 2023
Basic information
Item Serial Number
2023003318
License Number
In Vitro Water Permit No. 23-231
체외수허23-231호
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)
Siemens Healthineers Co., Ltd.
지멘스헬시니어스(주)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 390 호
Important dates & status
Item Approval Date
Jun 08, 2023
Business Permit Date
Apr 04, 2005
Expiration Period
2023-06-08 ~ 2028-06-07
Model information
Model Name
ADVIA Centaur CMV IgM (CMV IgM)
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 Permit No. 23-231. Approved on Jun 08, 2023. Registered by Siemens Healthineers Co., Ltd..

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