Architect i2000 system

제조사

  • 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
    SATP

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  • 모델명 / 제조번호(시리얼번호)
    8C89, 1G17
  • 제품 설명
    IVD: Chemiluminescent immunoassay analyser (CLIA)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    ARCHITECT i2000 System List Number 8C89-01; ARCHITECT i2000SR System System List Number 3M74-01 and 3M74-02; Wash Zone Mechanism Grounding Kit Part Number 7-201369-01; Concentrated Wash Buffer 1 L List Number 6C54-58 and l0 L List number 6C54-88.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. || ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiometric technology; and immunoassay tests utilizing chemiluminescent microparticle assay detection technology.
  • Manufacturer