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 Hydrotherapy No. 23-222. Approved on Jun 01, 2023. Registered by Roche Diagnostics Korea.
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MFDS Official Data
Unknown
Basic Information
Item Serial Number
2023003195
License Number
In Vitro Hydrotherapy No. 23-222
์ฒด์ธ์ํ23-222ํธ
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 ์ 730 ํธ
Important Dates & Status
Item Approval Date
Jun 01, 2023
Business Permit Date
May 27, 2005
Expiration Period
2023-06-01 ~ 2028-05-31
Model Information
Model Name
cobas Liat SARS-CoV-2 & Influenza A/B
