Access Immunoassay Systems

  • 모델명 / 제조번호(시리얼번호)
    Part Number: A54376, Synchron LXi 725 APF,  Lot Number: 722633, 823669. Part Number: A54377, Synchron LXi 725 AAF Lot Number: 722632, 823671.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • 제품 설명
    Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. || Part Number: A54376, Synchron LXi 725 APF, || Part Number: A54377, Synchron LXi 725 AAF. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 96 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Part Number: A19889, Access APF Wash Buffer REF 81907  Lot Number: 714944, 717432, 720808, 821426, 823659.  Part Number: A45144, Access APF Wash Buffer REF A16792  Lot Number: 714939, 717433, 720811, 821429, 823661.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • 제품 설명
    Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. || Part Number: A15518, Access 2 APF Wash Buffer REF 81907, || Part Number: A45142, Access 2 APF Wash Buffer II REF A16792. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number: A54378, UniCel DxC 600i APF,  Lot Numbers: 722631, 823677. Part Number: A54379, UniCel DxC 600i AAF, Lot Numbers: 722630, 823675.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • 제품 설명
    Access Immunoassay Systems Assay Protocol File (APF) Software versions for UniCel DxC 600i Systems. || Part Number: A54378, UniCel DxC 600i APF, || Part Number: A54379, UniCel DxC 600i AAF. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Number 81901, Lot Numbers: 13181168-13341170.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.
  • 제품 설명
    Access Immunoassay Systems Reaction Vessels. || The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States and Canada.
  • 제품 설명
    UniCel DxI 800 and 600 Access Immunoassay Systems, UniCel DxC 880i, 860i, 660i, and 680i SYNCHRON Access Clinical Systems with Dxl System Software versions 4.2 or 4.2.1. || In vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentrations found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Afghanistan, Algeria, Angola, Antigua and Barbuda, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Mexico, Morocco, Myanmar, Namibia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestinian Territory, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, Zambia, and Zimbabwe.
  • 제품 설명
    Access Immunoassay Systems, Part Number 81600N & 81600N. || An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.
  • Manufacturer
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