Device Recall Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS)

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV
  • 제품 설명
    Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    CSL Behring GmbH, Emil-von-Behring-Str. 76, Marburg Germany
  • 제조사 모회사 (2017)
  • Source
    USFDA