High-risk infection immunoassay reagent
๊ณ ์ํ์ฑ๊ฐ์ผ์ฒด๋ฉด์ญ๊ฒ์ฌ์์ฝ
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 23-25. Approved on Feb 01, 2023. Registered by Roche Diagnostics Korea.
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MFDS Official Data
Class III
Basic Information
Item Serial Number
2023000493
License Number
In vitro water 23-25
์ฒด์ธ์ํ23-25ํธ
Classification Number
K05030.01(3)
Device Class (Risk Classification)
Class III
Classification Name
High-risk infection immunoassay reagent
๊ณ ์ํ์ฑ๊ฐ์ผ์ฒด๋ฉด์ญ๊ฒ์ฌ์์ฝ
Official English Name
IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than โhigh risk pathogensโ, Infectious agents with moderate infectivity), immunological method
Company Information
Entity Address
์์ธํน๋ณ์ ๊ฐ๋จ๊ตฌ ํ
ํค๋๋ก108๊ธธ 22 , 4์ธต~8์ธต(๋์น๋, ์๊ฒฝ๋น๋ฉ)
Category
Import business
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Business License Number
์ฒด์ธ ์ 730 ํธ
Important Dates & Status
Item Approval Date
Feb 01, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-02-01 ~ 2028-01-31
For Export
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Model Information
Model Name
08355258190 1 case
08355258190์ธ 1๊ฑด
