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 Hydrotherapy No. 23-216. Approved on May 25, 2023. Registered by Abbott Korea.
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2023003092
License Number
In Vitro Hydrotherapy No. 23-216
์ฒด์ธ์ํ23-216ํธ
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 import business
์ฒด์ธ์ง๋จ์์
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Business License Number
์ฒด์ธ ์ 371 ํธ
Important Dates & Status
Item Approval Date
May 25, 2023
Business Permit Date
Mar 30, 2005
Expiration Period
2020-10-08 ~ 2027-04-30
Model Information
Model Name
ARCHITECT HAVAb-IgM Reagent Kit (6C30-22)
