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South Korea MFDS registration In Vitro No. 22-4

High-risk infection immunoassay reagent

KO: 고위험성감염체면역검사시약
South Korea flagSouth Korea·Unknown·Abbott Korea Diagnostics·Approved Jan 06, 2022
Basic information
Item Serial Number
2022000058
License Number
In Vitro No. 22-4
체외제허22-4호
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
Jan 06, 2022
Business Permit Date
Feb 05, 2014
Model information
Model Name
Panbio™ Malaria Pf Plus (05FK150-07)
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 No. 22-4. Approved on Jan 06, 2022. Registered by Abbott Korea Diagnostics.

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