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South Korea MFDS registration In vitro water 23-10

Genetic testing reagent for high-risk infections

KO: 고위험성감염체유전자검사시약
South Korea flagSouth Korea·Unknown·Biomeriu Korea Co., Ltd.·Approved Jan 11, 2023
Basic information
Item Serial Number
2023000211
License Number
In vitro water 23-10
체외수허23-10호
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)
Biomeriu Korea Co., Ltd.
(주)비오메리으코리아
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 687 호
Important dates & status
Item Approval Date
Jan 11, 2023
Business Permit Date
May 24, 2005
Expiration Period
2023-01-11 ~ 2028-01-10
Model information
Model Name
BioFire Blood Culture Identification 2 (BCID2) Panel
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 23-10. Approved on Jan 11, 2023. Registered by Biomeriu Korea Co., Ltd..

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