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South Korea MFDS registration In Vitro Reception No. 19-2864

Clinical Examination Universal Quality Control Substance I.

KO: 임상검사범용정도관리물질Ⅰ
South Korea flagSouth Korea·Class I·Mast Bio Co., Ltd.·Approved Nov 06, 2019
Basic information
Item Serial Number
2019006933
License Number
In Vitro Reception No. 19-2864
체외수신19-2864호
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)
Mast Bio Co., Ltd.
마스트바이오(주)
Entity Address
경기도 성남시 수정구 청계산로 734 5층(고등동, 마스트빌딩)
Manufacturer
VIRCELL,S.L
Category
Import business
수입업
Business License Number
체외 제 1194 호
Important dates & status
Item Approval Date
Nov 06, 2019
Business Permit Date
Feb 07, 2006
Expiration Period
2020-10-08 ~ 2030-09-30
For Export
아니오
Model information
Model Name
AMPLIRUN® TOTAL FLUA/FLUB/RSV CONTROL (SWAB)
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. 19-2864. Approved on Nov 06, 2019. Registered by Mast Bio Co., Ltd..

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