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Low-risk infection immunoassay reagent

์ €์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ

This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์‹ํ’ˆ์˜์•ฝํ’ˆ์•ˆ์ „์ฒ˜) under license number In vitro water21-4323. Approved on Jul 08, 2021. Registered by Mast Bio Co., Ltd..

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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2021003808
License Number
In vitro water21-4323
์ฒด์™ธ์ˆ˜์ธ21-4323ํ˜ธ
Classification Number
K05040.01
Device Class (Risk Classification)
Unknown
Classification Name
Low-risk infection immunoassay reagent
์ €์œ„ํ—˜์„ฑ๊ฐ์—ผ์ฒด๋ฉด์—ญ๊ฒ€์‚ฌ์‹œ์•ฝ
Official English Name
IVD reagents for Infectious disease marker(Detection of low infectivity pathogen), immunological method
Company Information
Entity Name (Company)
Mast Bio Co., Ltd.
๋งˆ์ŠคํŠธ๋ฐ”์ด์˜ค(์ฃผ)
Category
In vitro diagnostic import business
์ฒด์™ธ์ง„๋‹จ์ˆ˜์ž…์—…
Business License Number
์ฒด์™ธ ์ œ 1194 ํ˜ธ
Important Dates & Status
Item Approval Date
Jul 08, 2021
Business Permit Date
Feb 07, 2006
Expiration Period
2021-07-08 ~ 2026-07-07
Model Information
Model Name
C.DIFF QUIK CHEK COMPLETE
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DJ Fang

DJ Fang

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