Device Recall Specimen Gate Laboratory eReports

  • 모델명 / 제조번호(시리얼번호)
    Software Version 1.0
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru
  • 제품 설명
    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 || Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
  • 제조사 모회사 (2017)
  • Source
    USFDA