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South Korea MFDS registration In Vitro Water Treatment No. 24-34

Genetic testing reagent for high-risk infections

KO: 고위험성감염체유전자검사시약
South Korea flagSouth Korea·Unknown·Biomeriu Korea Co., Ltd.·Approved Feb 15, 2024
Basic information
Item Serial Number
2024000856
License Number
In Vitro Water Treatment No. 24-34
체외수허24-34호
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
Feb 15, 2024
Business Permit Date
May 24, 2005
Expiration Period
2024-02-15 ~ 2029-02-14
Model information
Model Name
BioFire Joint Infection(JI) 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 Treatment No. 24-34. Approved on Feb 15, 2024. Registered by Biomeriu Korea Co., Ltd..

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