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South Korea MFDS registration In Vitro Hydrotherapy No. 23-216

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Abbott Korea·Approved May 25, 2023
Basic information
Item Serial Number
2023003092
License Number
In Vitro Hydrotherapy No. 23-216
체외수허23-216호
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)
Abbott Korea
한국애보트(유)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 371 호
Important dates & status
Item Approval Date
May 25, 2023
Business Permit Date
Mar 30, 2005
Expiration Period
2020-10-08 ~ 2027-04-30
Model information
Model Name
ARCHITECT HAVAb-IgM Reagent Kit (6C30-22)
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 Hydrotherapy No. 23-216. Approved on May 25, 2023. Registered by Abbott Korea.

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