Immunoassay System

제조사

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 336 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    All versions are affected.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution & Canada
  • 제품 설명
    Access Immunoassay Systems, Part Number: 81600 ; Access 2 Immunoassay Systems, Part Number: 81600N; || Synchron LXi 725; UniCel DxI 800 Access Immunoassay Systems, Part Number: 973100; UniCel DxI 600 Access Immunoassay Systems, Part Number A30260; || UniCel DxC 600i, Part Number: A25656; UniCel DxC 660i, Part Number: A64871; UniCel DxC 860i, Part Number: A64935; UniCel DxC 880i, Part Number: A59102; SYNCHRON Access Clinical || Systems || The Access/DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitive or qualitative determination of various analyte concentration found in human body fluids. Function of the Peristaltic Pump: to aspirate unbound material from reaction vessels and to move waste from vacuum jar into waste bottle through associated tubing within the Access Immunoassay System.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot # 913348
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada.
  • 제품 설명
    Access¿ Immunoassay Systems || UNCONJUGATED ESTRIOL || Part # 33570 || The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 917074, 008534  Expiration Date: 917074 (12/31/10), 008534 (2/28/11)
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • 제품 설명
    Access¿ Immunoassay Systems Total T4 Calibrators, || Part Number: 33805, || Subsequent Product Code: JIS || The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    019818, 021654, 024072
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Ethiopia, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Macao, Malaysia, Mexico, Netherlands, Nigeria, Pakistan, Panama, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
  • 제품 설명
    Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. || The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • 제품 설명
    Access Immunoassay System, || Access 2 Immunoassay System, || Synchron LXi 725 Clinical || System, UniCel DxC 600i || Synchron Access Clinical System || Part Numbers: Access  81600; || Access 2  81600N, 386220, A69186, A25656, A12900; || Access 2 (LXi)  A15642; || Access 2 Section, DxC 600i  A25640. || 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. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer.
  • Manufacturer
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