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 In Vitro Drug No. 23-342. Approved on Mar 13, 2023. Registered by SDBiosensor Co., Ltd..
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2023001459
License Number
In Vitro Drug No. 23-342
์ฒด์ธ์ ํ23-342ํธ
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 Manufacturing
์ฒด์ธ์ง๋จ์ ์กฐ์
Business License Number
์ฒด์ธ ์ 4413 ํธ
Important Dates & Status
Item Approval Date
Mar 13, 2023
Business Permit Date
Jan 10, 2014
Model Information
Model Name
STANDARDโข M10 HPV (M10-HPV-01)
