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 Water Treatment No. 24-34. Approved on Feb 15, 2024. Registered by Biomeriu Korea Co., Ltd..
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2024000856
License Number
In Vitro Water Treatment No. 24-34
์ฒด์ธ์ํ24-34ํธ
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
์ฒด์ธ์ง๋จ์์
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Business License Number
์ฒด์ธ ์ 687 ํธ
Important Dates & Status
Item Approval Date
Feb 15, 2024
Business Permit Date
May 24, 2005
Expiration Period
2024-02-15 ~ 2029-02-14
Model Information
Model Name
BioFire Joint Infection(JI) Panel
