Device Recall Epi proColon Plasma Quick Kit

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 16903908; Expiration Date: 28 Feb 2018
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Shipped to one U.S. distributor in NY. Further distributed in 9 states: CA, MI, NC, NE, NJ, PA, TN, TX, UT.
  • 제품 설명
    Epi proColon Plasma Quick Kit; Catalog Number: M5-02-001: Consists of 1x Lysis Binding Buffer, 1x Wash B Concentrate, 1x Dilution Buffer, 4x Bisulfate Solution, 1x Protection Buffer; UDI: (01)04260400670036(17)180228(10)1603908;
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Epigenomics Ag, Geneststr. 5, Berlin Germany
  • 제조사 모회사 (2017)
  • Source
    USFDA