High-risk infection immunoassay reagent
๊ณ ์ํ์ฑ๊ฐ์ผ์ฒด๋ฉด์ญ๊ฒ์ฌ์์ฝ
This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / ์ํ์์ฝํ์์ ์ฒ) under license number In Vitro No. 22-114. Approved on Feb 18, 2022. Registered by Abbott Korea Diagnostics.
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2022000837
License Number
In Vitro No. 22-114
์ฒด์ธ์ ํ22-114ํธ
Classification Number
K05030.01
Device Class (Risk Classification)
Unknown
Classification Name
High-risk infection immunoassay reagent
๊ณ ์ํ์ฑ๊ฐ์ผ์ฒด๋ฉด์ญ๊ฒ์ฌ์์ฝ
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), immunological method
Company Information
Category
In Vitro Diagnostic Manufacturing
์ฒด์ธ์ง๋จ์ ์กฐ์
Business License Number
์ฒด์ธ ์ 4452 ํธ
Important Dates & Status
Item Approval Date
Feb 18, 2022
Business Permit Date
Feb 05, 2014
Model Information
Model Name
Panbioโข COVID-19/Flu A&B Rapid Panel (62FK21)
