Devices

Access Immunoassay Systems

  • Model / Serial
    DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States and Canada.
  • Product Description
    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
    Beckman Coulter Inc.
  • 1 Event

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA

96 devices with a similar name

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Device Recall Access Ferritin Calibrators for Access Ferritin assay on the Access Immunoassay Sy...
  • Model / Serial
    Lot No. 671094
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Zimbabwe.
  • Product Description
    Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
  • Manufacturer
    Beckman Coulter Inc.
Device Recall Access Immunoassay Systems, Discrete photometric chemistry analyzer
  • Model / Serial
    Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada
  • Product Description
    Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
  • Manufacturer
    Beckman Coulter Inc
Access Immunoassay Systems Assay Protocol: Dil-AFP.
UniCel DxI 600 Access Immunoassay Systems, UniCel DxI 800 Access Immunoassay Systems, UniCel DxC ...
UniCel DxI Access Immunoassay Systems Reaction Vessels
  • Model / Serial
  • Product Description
    In-vitro diagnostics
  • Manufacturer
    Beckman Coulter
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