South Korea MFDS registration In vitro water 22-109
Accompanying diagnostic histopathology test reagent
KO: 동반진단용조직병리검사시약
South Korea·Class III·Agilent Technologies Korea·Approved May 17, 2022Basic information
- Item Serial Number
- 2022002575
- License Number
- In vitro water 22-109
- Classification Number
- O04020.01(3)
- Device Class (Risk Classification)
- Class III
- Classification Name
- Accompanying diagnostic histopathology test reagent
- Official English Name
- IVD reagents for companion diagnostics with protein level
체외수허22-109호
동반진단용조직병리검사시약
Company information
- Entity Address
- 서울특별시 서초구 강남대로 369 , 13층, 14층
- Manufacturer
- Agilent Technologies, Inc.
- Category
- Import business
- Business License Number
- 체외 제 1907 호
수입업
Important dates & status
- Item Approval Date
- May 17, 2022
- Business Permit Date
- Jan 18, 2010
- Expiration Period
- 2022-05-17 ~ 2027-05-16
- For Export
- 아니오
Model information
- Model Name
- PD-L1 IHC 22C3 pharmDx (Dako Omnis), GE006
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 22-109. Approved on May 17, 2022. Registered by Agilent Technologies Korea.
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