Devices

Device Recall Coaguchek

  • 모델명 / 제조번호(시리얼번호)
    Lots 469A and 475A; exp. 6/30/2008.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide-California, Georgia, Louisiana, Maryland, Oklahoma and Texas.
  • 제품 설명
    CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use).
  • Manufacturer
    Roche Diagnostics Corp.
  • 1 Event

제조사

Roche Diagnostics Corp.
  • 제조사 주소
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46250-0416
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 8 건

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Device Recall CoaguChek Pro DM System
Device Recall CoaguChek Plus
Device Recall CoaguChek test strips
Device Recall CoaguChek XS Pro meters
  • 모델명 / 제조번호(시리얼번호)
    catalog number 05530199160
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. || Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
  • Manufacturer
    Roche Diagnostics Operations, Inc.
Device Recall CoaguChek XS Pro System
  • 모델명 / 제조번호(시리얼번호)
    Model/Catalog/Part Number: 05530199160
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    CoaguChek XS Pro System || The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
  • Manufacturer
    Roche Diagnostics Operations, Inc.
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