South Korea MFDS registration In vitro water 22-242
HIV· HBV· HCV· HTLV Diagnostic Immunoassay Reagent
KO: HIV·HBV·HCV·HTLV진단면역검사시약
South Korea·Class IV·Biorad Korea Co., Ltd.·Approved Nov 08, 2022Basic information
- Item Serial Number
- 2022005700
- License Number
- In vitro water 22-242
- Classification Number
- K05010.01(4)
- Device Class (Risk Classification)
- Class IV
- Classification Name
- HIV· HBV· HCV· HTLV Diagnostic Immunoassay Reagent
- Official English Name
- IVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method
체외수허22-242호
HIV·HBV·HCV·HTLV진단면역검사시약
Company information
- Entity Address
- 서울특별시 강남구 역삼로 114 ,10층(역삼동,현죽빌딩)
- Manufacturer
- Bio-Rad
- Category
- Import business
- Business License Number
- 체외 제 719 호
수입업
Important dates & status
- Item Approval Date
- Nov 08, 2022
- Business Permit Date
- May 26, 2005
- Expiration Period
- 2022-11-08 ~ 2027-11-07
- For Export
- 아니오
Model information
- Model Name
- C28430
About this record
This Class IV medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In vitro water 22-242. Approved on Nov 08, 2022. Registered by Biorad Korea Co., Ltd..
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