ARCHITECT

  • 모델명 / 제조번호(시리얼번호)
    ARCHITECT c4000 Cuvette Segment 02P75-01 Not applicable ARCHITECT c8000 Cuvette Segment 01G46-01 Not applicable ARCHITECT c16000 Cuvette Segment 09D32-05 Not applicable
  • Manufacturer
  • 1 Event

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
    AMPMDRS

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 695 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    The RS-232 Manual is not controlled by control or lot numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore
  • 제품 설명
    ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers C800174 through C800346 and the following Serial numbers: C800072, C800122, C800131, and C800142
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distrbued nationwide and to the following foreign countries: Mexico, Australia, Germany, Hong Kong, Canada, Thailand, Grand Cayman, Chile, New Zealand, Columbia, Brazil, and Singapore.
  • 제품 설명
    ARCHITECT c8000 Processing Module; List Number 01G06-01. Manufactured by Toshiba Corporation, Medical Systems Division, Japan. Distributed by Abbott Laboratories Diagnostic Division, Irving, Texas
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot 14032HW00 Exp November 17, 2005 and lot 17054HW00 Exp November 17, 2005.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and to Mexico, Columbia, Ecuador, Brazil, Puerto Rico, Domincan Republic, Canada, Germany, Singapore, Hong Kong, India, Thailand, Australia, New Zealand, Bahamas.
  • 제품 설명
    Abbott Clinical Chemistry AEROSET/ ARCHITECT c8000 Creatinine. List No. 7D64-20
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    List 6C09-20, lots 11002M300, 11003M300, 16051M200, 18288M300; List 6C09-25, lots 11002M301, 16051M201, 18288M301
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Canada, Germany, Singapore, Hong Kong, Australia, New Zealand and Japan.
  • 제품 설명
    ARCHITECT B12 Reagents, List 6C09-20 (4 x 100 tests) and List 6C09-25 (100 tests); Abbott Laboratories, Abbott Park, IL 60064 USA; Abbott, Max-Planck-Ring 2, 65205 Wiesbaden, Germany
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    list 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Canada, Japan, Australia, New Zealand, Germany and England
  • 제품 설명
    Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
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