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ABO· Blood type immunoassay reagent other than RhD

ABO·RhD이외의혈액형면역검사시약

This Class III medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In vitro water 22-262. Approved on Nov 24, 2022. Registered by Biorad Korea Co., Ltd..

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MFDS Official Data
Class III
Basic Information
Item Serial Number
2022006069
License Number
In vitro water 22-262
체외수허22-262호
Classification Number
L02020.01(3)
Device Class (Risk Classification)
Class III
Classification Name
ABO· Blood type immunoassay reagent other than RhD
ABO·RhD이외의혈액형면역검사시약
Official English Name
IVD reagents for blood typing other than ABO·RhD, red cell agglutination
Company Information
Entity Name (Company)
Biorad Korea Co., Ltd.
한국바이오래드(주)
Entity Address
서울특별시 강남구 역삼로 114 ,10층(역삼동,현죽빌딩)
Manufacturer
DiaMed GmbH
Category
Import business
수입업
Business License Number
체외 제 719 호
Important Dates & Status
Item Approval Date
Nov 24, 2022
Business Permit Date
May 26, 2005
Expiration Period
2022-11-24 ~ 2027-11-23
For Export
아니오
Model Information
Model Name
1 002234 case
002234외 1건
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