Medical enzyme immunoassay device
์๋ฃ์ฉํจ์๋ฉด์ญ๊ฒ์ฌ์ฅ์น
This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In Vitro Reception No. 24-85. Approved on Jan 18, 2024. Registered by Mast Bio Co., Ltd..
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2024000317
License Number
In Vitro Reception No. 24-85
์ฒด์ธ์์ 24-85ํธ
Classification Number
K01010.01
Device Class (Risk Classification)
Unknown
Classification Name
Medical enzyme immunoassay device
์๋ฃ์ฉํจ์๋ฉด์ญ๊ฒ์ฌ์ฅ์น
Official English Name
Enzyme immunoassay/ELISA analyzer
Company Information
Category
In vitro diagnostic import business
์ฒด์ธ์ง๋จ์์
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Business License Number
์ฒด์ธ ์ 1194 ํธ
Important Dates & Status
Item Approval Date
Jan 18, 2024
Business Permit Date
Feb 07, 2006
Expiration Period
2024-01-18 ~ 2029-01-17
Model Information
Model Name
ChemWell 2
