South Korea MFDS registration In Vitro Drug No. 23-1159
Genetic testing reagent for high-risk infections
KO: 고위험성감염체유전자검사시약
South Korea·Unknown·Bodytech Med Co., Ltd.·Approved Dec 20, 2023Basic information
- Item Serial Number
- 2023007190
- License Number
- In Vitro Drug No. 23-1159
- 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
체외제허23-1159호
고위험성감염체유전자검사시약
Company information
- Category
- In Vitro Diagnostic Manufacturing
- Business License Number
- 체외 제 1500 호
체외진단제조업
Important dates & status
- Item Approval Date
- Dec 20, 2023
- Business Permit Date
- Nov 22, 2002
Model information
- Model Name
- ExAmplex MTB/NTM kit
About this record
This Unknown medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Drug No. 23-1159. Approved on Dec 20, 2023. Registered by Bodytech Med Co., Ltd..
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