Access Immunoassay Systems

  • 모델명 / 제조번호(시리얼번호)
    All Serial Numbers
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and Puerto Rico and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayette, Mexico, Morocco, Nambia, Netherlands, New Zealand, Norway, Philippines, Poland,, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Venezuela and Vietnam.
  • 제품 설명
    Access Immunoassay Systems Part Number: 81600 || Access 2 Immunoassay Systems Part Number: 81600N || Access Immunoassay Systems LXi 725 Part Number: 386200 || Subsequent Product Codes: JGS || The Access/DxI 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
  • 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)
    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
  • 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
    UniCel DxC 600i Access Immunoassay Systems, Part Number A25656. || An in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All lot numbers
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and country of: Canada.
  • 제품 설명
    Access Immunoassay Systems Thyroglobulin, || Part Number: 33860 || This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Access Immunoassay Systems Enhanced AccuTnI Reagent Kit
  • Manufacturer
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