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South Korea MFDS registration In Vitro Drug No. 23-1018

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Abbott Korea Diagnostics·Approved Oct 31, 2023
Basic information
Item Serial Number
2023006181
License Number
In Vitro Drug No. 23-1018
체외제허23-1018호
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 Diagnostics
(주)한국애보트진단
Category
In Vitro Diagnostic Manufacturing
체외진단제조업
Business License Number
체외 제 4452 호
Important dates & status
Item Approval Date
Oct 31, 2023
Business Permit Date
Feb 05, 2014
Model information
Model Name
Panbio™ COVID-19/Flu A&B Self Test (62FK51, 62FK71, 62FK81, 62FK91-01)
Panbio™ COVID-19/Flu A&B Panel Self Test (62FK51, 62FK71, 62FK81, 62FK91-01)
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. 23-1018. Approved on Oct 31, 2023. Registered by Abbott Korea Diagnostics.

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