South Korea MFDS registration In Vitro Formulation No. 23-39
High-risk infection immunoassay reagent
KO: 고위험성감염체면역검사시약
South Korea·Class III·Abbott Korea Diagnostics·Approved Jan 18, 2023Basic information
- Item Serial Number
- 2023000323
- License Number
- In Vitro Formulation No. 23-39
- Classification Number
- K05030.01(3)
- Device Class (Risk Classification)
- Class III
- Classification Name
- High-risk infection immunoassay reagent
- 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
체외제허23-39호
고위험성감염체면역검사시약
Company information
- Entity Address
- 경기도 용인시 기흥구 하갈로15번길 46 (보라동)
- Category
- Manufacturing
- Business License Number
- 체외 제 4452 호
제조업
Important dates & status
- Item Approval Date
- Jan 18, 2023
- Business Permit Date
- Feb 05, 2014
- Expiration Period
- 2023-01-18 ~ 2028-01-17
- For Export
- 아니오
Model information
- Model Name
- 41FK16 and 1 other case
41FK16외 1건
About this record
This Class III medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Formulation No. 23-39. Approved on Jan 18, 2023. Registered by Abbott Korea Diagnostics.
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