Abbott Point of Care

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 14 건

  • 모델명 / 제조번호(시리얼번호)
    04J50-01, 04J50-02, 03P89-24 | R13149A, R13151, R13151A, lots from C13139 to C13270A
  • 제품 설명
    IVD: Prothrombin time kit
  • 모델명 / 제조번호(시리얼번호)
    O4J50·01, O4J50·02, 031'89·24 | PTf1NR 10lS beginning with RI I or RI2
  • 제품 설명
    IVD: Prothrombin time kit
  • 모델명 / 제조번호(시리얼번호)
    06F15-03, 06F15-04, 03P90-25, 600-9009-25
  • 제품 설명
    IVD: Troponin kit
  • 모델명 / 제조번호(시리얼번호)
    03P90-25, 06F15-03, 06F15-04, 600-9009-25 | Lots beginning with letter "T", See FSN
  • 제품 설명
    IVD: Troponin control
  • 모델명 / 제조번호(시리얼번호)
    07G01-0l, 07G01-02, 03P86-25, 600-9006-25
  • 제품 설명
    IVD: Activated whole blood clotting time kit
하나 더 9 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 20 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NZMMDSA
  • 제조사 주소
    Abbott Point Of Care Inc., 400 College Rd E, Princeton NJ 08540-6607
  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA
  • 제조사 주소
    Abbott Point of Care Inc., 104 Windsor Center Dr, East Windsor NJ 08520-1407
  • Source
    USFDA
  • 제조사 모회사 (2017)
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    AEMPSVFOI
하나 더 15 건 더