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South Korea MFDS registration In Vitro Jane No. 24-109

Low-risk infection immunoassay reagent

KO: 저위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Bodytech Med Co., Ltd.·Approved Jan 29, 2024
Basic information
Item Serial Number
2024000517
License Number
In Vitro Jane No. 24-109
체외제인24-109호
Classification Number
K05040.01
Device Class (Risk Classification)
Unknown
Classification Name
Low-risk infection immunoassay reagent
저위험성감염체면역검사시약
Official English Name
IVD reagents for Infectious disease marker(Detection of low infectivity pathogen), 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
Jan 29, 2024
Business Permit Date
Nov 22, 2002
Model information
Model Name
REF: SMFP-178, AFIAS H.pylori SA
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 Jane No. 24-109. Approved on Jan 29, 2024. Registered by Bodytech Med Co., Ltd..

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