South Korea MFDS registration Extracorporeal Water No. 22-216
Genetic testing reagent for high-risk infections
KO: 고위험성감염체유전자검사시약
South Korea·Unknown·Abbott Korea·Approved Oct 11, 2022Basic information
- Item Serial Number
- 2022005136
- License Number
- Extracorporeal Water No. 22-216
- Classification Number
- N05030.01
- Device Class (Risk Classification)
- Unknown
- Classification Name
- Genetic testing reagent for high-risk infections
- 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
체외수허22-216호
고위험성감염체유전자검사시약
Company information
- Category
- In vitro diagnostic import business
- Business License Number
- 체외 제 371 호
체외진단수입업
Important dates & status
- Item Approval Date
- Oct 11, 2022
- Business Permit Date
- Mar 30, 2005
- Expiration Period
- 2022-10-11 ~ 2027-10-10
Model information
- Model Name
- Alinity m EBV AMP Kit (US-FDA_09N43-095)
About this record
This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number Extracorporeal Water No. 22-216. Approved on Oct 11, 2022. Registered by Abbott Korea.
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