Devices

Access Immunoassay Systems

  • Model / Serial
    Part Number: A54378, UniCel DxC 600i APF,  Lot Numbers: 722631, 823677. Part Number: A54379, UniCel DxC 600i AAF, Lot Numbers: 722630, 823675.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Product Description
    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
    Beckman Coulter Inc.
  • 1 Event

Manufacturer

Beckman Coulter Inc.
  • Manufacturer Address
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Manufacturer Parent Company (2017)
    Danaher Corporation
  • Source
    USFDA

96 devices with a similar name

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Beckman Coulter UniCel DxI and DxC Access Immunoassay Systems
  • Model / Serial
    Model: Models: DxI 800, DxI 600, DxC 660i, 680i, 860i, 880i, Affected: Specified serial number ranges
  • Manufacturer
    Beckman Coulter Inc
uni cel dxl access software immunoassay, includes software used on the unicel dxi 800 and unicel ...
unicel dxi 800 access immunoassay systems, unicel dxi 600 access immunoassay systems, unicel dxc ...
Cortisol reagent used on Access immunoassay systems
  • Model / Serial
  • Product Description
    in-vitro_medical_device
  • Manufacturer
    BECKMAN COULTER
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.
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