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South Korea MFDS registration In Vitro Drug No. 23-1138

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Bodytech Med Co., Ltd.·Approved Dec 14, 2023
Basic information
Item Serial Number
2023007060
License Number
In Vitro Drug No. 23-1138
체외제허23-1138호
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)
Bodytech Med Co., Ltd.
바디텍메드(주)
Category
In Vitro Diagnostic Manufacturing
체외진단제조업
Business License Number
체외 제 1500 호
Important dates & status
Item Approval Date
Dec 14, 2023
Business Permit Date
Nov 22, 2002
Model information
Model Name
iroma™ COVID-19/Flu A+B/RSV Ag Combo
ichroma™ COVID-19/Flu A+B/RSV Ag Combo
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. 23-1138. Approved on Dec 14, 2023. Registered by Bodytech Med Co., Ltd..

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