South Korea MFDS registration In vitro water 21-1
Accompanying diagnostic histopathology test reagent
KO: 동반진단용조직병리검사시약
South Korea·Class III·Agilent Technologies Korea·Approved Jan 06, 2021Basic information
- Item Serial Number
- 2020008084
- License Number
- In vitro water 21-1
- 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
체외수허21-1호
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
- Jan 06, 2021
- Business Permit Date
- Jan 18, 2010
- Expiration Period
- 2021-01-06 ~ 2026-01-05
- For Export
- 아니오
Model information
- Model Name
- PD-L1 IHC 28-8 pharmDx, SK005
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 21-1. Approved on Jan 06, 2021. Registered by Agilent Technologies Korea.
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