HIV· HBV· HCV· HTLV Diagnostic Immunoassay Reagent
HIV·HBV·HCV·HTLV진단면역검사시약
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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MFDS Official Data
Class IV
Basic Information
Item Serial Number
2022005700
License Number
In vitro water 22-242
체외수허22-242호
Classification Number
K05010.01(4)
Device Class (Risk Classification)
Class IV
Classification Name
HIV· HBV· HCV· HTLV Diagnostic Immunoassay Reagent
HIV·HBV·HCV·HTLV진단면역검사시약
Official English Name
IVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method
Company Information
Entity Address
서울특별시 강남구 역삼로 114 ,10층(역삼동,현죽빌딩)
Manufacturer
Bio-Rad
Category
Import business
수입업
Business License Number
체외 제 719 호
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
