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South Korea MFDS registration In vitro 22-4542

General immunoassay reagent

KO: 일반면역검사시약
South Korea flagSouth Korea·Unknown·Beckman Coulter Korea·Approved Nov 21, 2022
Basic information
Item Serial Number
2022005982
License Number
In vitro 22-4542
체외수인22-4542호
Classification Number
K02050.01
Device Class (Risk Classification)
Unknown
Classification Name
General immunoassay reagent
일반면역검사시약
Official English Name
IVD reagents for general immune test
Company information
Entity Name (Company)
Beckman Coulter Korea
한국벡크만쿨터(주)
Category
In vitro diagnostic import business
체외진단수입업
Business License Number
체외 제 1783 호
Important dates & status
Item Approval Date
Nov 21, 2022
Business Permit Date
Mar 20, 2009
Expiration Period
2022-11-21 ~ 2027-11-20
Model information
Model Name
Lp(a) Ultra
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 22-4542. Approved on Nov 21, 2022. Registered by Beckman Coulter Korea.

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