Accompanying diagnostic histopathology test reagent
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This Class III medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In vitro water 21-1. Approved on Jan 06, 2021. Registered by Agilent Technologies Korea.
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MFDS Official Data
Class III
Basic Information
Item Serial Number
2020008084
License Number
In vitro water 21-1
์ฒด์ธ์ํ21-1ํธ
Classification Number
O04020.01(3)
Device Class (Risk Classification)
Class III
Classification Name
Accompanying diagnostic histopathology test reagent
๋๋ฐ์ง๋จ์ฉ์กฐ์ง๋ณ๋ฆฌ๊ฒ์ฌ์์ฝ
Official English Name
IVD reagents for companion diagnostics with protein level
Company Information
Entity Address
์์ธํน๋ณ์ ์์ด๊ตฌ ๊ฐ๋จ๋๋ก 369 , 13์ธต, 14์ธต
Manufacturer
Agilent Technologies, Inc.
Category
Import business
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Business License Number
์ฒด์ธ ์ 1907 ํธ
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
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Model Information
Model Name
PD-L1 IHC 28-8 pharmDx, SK005
