Devices

Device Recall CoaguChek XS System (HCP)

  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog/Part Number: 04837975001 and 04625412160
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    CoaguChek XS System (HCP) || The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

제조사

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA