South Korea MFDS registration In Vitro Reception No. 19-2417

Clinical Examination Universal Quality Control Substance I.

KO: 임상검사범용정도관리물질Ⅰ
South Korea flagSouth Korea·Class I·Biorad Korea Co., Ltd.·Approved Sep 25, 2019
Basic information
Item Serial Number
2019005942
License Number
In Vitro Reception No. 19-2417
체외수신19-2417호
Classification Number
J08060.01(1)
Device Class (Risk Classification)
Class I
Classification Name
Clinical Examination Universal Quality Control Substance I.
임상검사범용정도관리물질Ⅰ
Official English Name
General calibrators, controls or standards, classⅠ, for clinical chemistry
Company information
Entity Name (Company)
Biorad Korea Co., Ltd.
한국바이오래드(주)
Entity Address
서울특별시 강남구 역삼로 114 ,10층(역삼동,현죽빌딩)
Manufacturer
Bio-Rad Laboratories Inc.
Category
Import business
수입업
Business License Number
체외 제 719 호
Important dates & status
Item Approval Date
Sep 25, 2019
Business Permit Date
May 26, 2005
Expiration Period
2020-10-08 ~ 2030-09-30
For Export
아니오
Model information
Model Name
VIROTROL ToRCH-M(00117A)
About this record

This Class I medical device is registered with South Korea's Ministry of Food and Drug Safety (MFDS / 식품의약품안전처) under license number In Vitro Reception No. 19-2417. Approved on Sep 25, 2019. Registered by Biorad Korea Co., Ltd..

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