Abbott

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 59 건

  • 모델명 / 제조번호(시리얼번호)
    AxSYM Free T4 Standard Calibrators, LN 7K51-01, Lot Number 96238JN00, Expiry 05 January 2012. AxSYM Free T4 Controls, LN 7K51-10, Lot Number 96197JN00, Expiry 22 January 2012.
  • 제품 설명
    IVD, Calibrators
  • 모델명 / 제조번호(시리얼번호)
    List Number: 08H67-01; 08H67-03 Serial Numbers: All serial numbers below 70594BG UDI: 00380740017170; 00380740099916
  • 제품 설명
    CELL-DYN Ruby
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers : 38901UI00, 38901UI01 Expiry 29 January 2015
  • 제품 설명
    IVD Test Reagent/Kits, Immunoassay
  • 모델명 / 제조번호(시리얼번호)
    Product : Lipase Reagent, List Number (LN) : 7D80 Lot numbers : 43827UQ12, 43994UQ07, 43819UQ03, 4596UQ08, 44449UQ05, 44775UQ09, 44127UQ06, 44930UQ11, 44334UQ07
  • 제품 설명
    IVD, SmartWash for Triglyceride, Lipase
  • 모델명 / 제조번호(시리얼번호)
    List Number: 09P68‐01 Multiple serial numbers of the affected device are provided in the attached FSN.
  • 제품 설명
    Analyzers, Laboratory, Clinical Chemistry/Immunoassay
하나 더 54 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 471 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
  • 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
    NIDFSINVIMA
하나 더 466 건 더