Genetic testing reagent for high-risk infections
๊ณ ์ํ์ฑ๊ฐ์ผ์ฒด์ ์ ์๊ฒ์ฌ์์ฝ
This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number Extracorporeal Water No. 22-216. Approved on Oct 11, 2022. Registered by Abbott Korea.
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2022005136
License Number
Extracorporeal Water No. 22-216
์ฒด์ธ์ํ22-216ํธ
Classification Number
N05030.01
Device Class (Risk Classification)
Unknown
Classification Name
Genetic testing reagent for high-risk infections
๊ณ ์ํ์ฑ๊ฐ์ผ์ฒด์ ์ ์๊ฒ์ฌ์์ฝ
Official English Name
IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than 'high risk pathogens', Infectious agents with moderate infectivity), molecular diagnostics
Company Information
Category
In vitro diagnostic import business
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Business License Number
์ฒด์ธ ์ 371 ํธ
Important Dates & Status
Item Approval Date
Oct 11, 2022
Business Permit Date
Mar 30, 2005
Expiration Period
2022-10-11 ~ 2027-10-10
Model Information
Model Name
Alinity m EBV AMP Kit (US-FDA_09N43-095)
