South Korea MFDS registration In vitro water 22-262
ABO· Blood type immunoassay reagent other than RhD
KO: ABO·RhD이외의혈액형면역검사시약
Basic information
- Item Serial Number
- 2022006069
- License Number
- In vitro water 22-262
- Classification Number
- L02020.01(3)
- Device Class (Risk Classification)
- Class III
- Classification Name
- ABO· Blood type immunoassay reagent other than RhD
- Official English Name
- IVD reagents for blood typing other than ABO·RhD, red cell agglutination
체외수허22-262호
ABO·RhD이외의혈액형면역검사시약
Company information
- Entity Address
- 서울특별시 강남구 역삼로 114 ,10층(역삼동,현죽빌딩)
- Manufacturer
- DiaMed GmbH
- Category
- Import business
- Business License Number
- 체외 제 719 호
수입업
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
About this record
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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