High-risk infection immunoassay 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 Formulation No. 23-39. Approved on Jan 18, 2023. Registered by Abbott Korea Diagnostics.
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MFDS Official Data
Class III
Basic Information
Item Serial Number
2023000323
License Number
In Vitro Formulation No. 23-39
์ฒด์ธ์ ํ23-39ํธ
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
๊ฒฝ๊ธฐ๋ ์ฉ์ธ์ ๊ธฐํฅ๊ตฌ ํ๊ฐ๋ก15๋ฒ๊ธธ 46 (๋ณด๋ผ๋)
Category
Manufacturing
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Business License Number
์ฒด์ธ ์ 4452 ํธ
Important Dates & Status
Item Approval Date
Jan 18, 2023
Business Permit Date
Feb 05, 2014
Expiration Period
2023-01-18 ~ 2028-01-17
For Export
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Model Information
Model Name
41FK16 and 1 other case
41FK16์ธ 1๊ฑด
