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South Korea MFDS registration In Vitro No. 22-507

Infectious agent diagnostic immunoassay reagent

KO: 감염체 진단 면역검사시약
South Korea flagSouth Korea·Unknown·Abbott Korea Diagnostics·Approved Jul 29, 2022
Basic information
Item Serial Number
2022003933
License Number
In Vitro No. 22-507
체외제허22-507호
Classification Number
K05000
Device Class (Risk Classification)
Unknown
Classification Name
Infectious agent diagnostic immunoassay reagent
감염체 진단 면역검사시약
Official English Name
IVD reagent for infectious disease, 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
Jul 29, 2022
Business Permit Date
Feb 05, 2014
Expiration Period
2022-07-29 ~ 2027-07-28
Model information
Model Name
Panbio™ COVID-19 Ag Self-Test-02
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. 22-507. Approved on Jul 29, 2022. Registered by Abbott Korea Diagnostics.

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