Devices

Access Immunoassay Systems

  • Model / Serial
    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.
  • 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 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
    Beckman Coulter Inc.
  • 2 Events

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

Learn more about the data here

Access Immunoassay Systems Access Folate Calibrators, An in vitro diagnostic medical device (IVD)
  • Model / Serial
    Access Immunoassay Systems Access Folate Calibrators, Part numbers: A14207, A98033. An in vitro diagnostic medical device (IVD)Part Number: A14207Lot Numbers: 112788 (Expiry Date 30 JUN 2012); 115741 (31 AUG 2012); 118917 (31 OCT 2012)Part Number: A98033Lot Numbers: 122651 (31 JUL 2012); 123635 (30 SEP 2012); 219962 (31 OCT 2012)
  • Manufacturer
    Beckman Coulter Australia Pty Ltd
Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical devic...
  • Model / Serial
    Access hLH Calibrators used with Access Immunoassay Systems. An in vitro diagnostic medical device (IVD)Multiple Lot Numbers
  • Manufacturer
    Beckman Coulter Australia Pty Ltd
UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC ...
  • Model / Serial
    UniCel DxI 800 Access Immunoassay Systems, Unicel DxI 600 Access Immunoassay Systems, UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical System. In vitro diagnostic medical devices (IVDs)Part numbers: 973100, A30260, A71456, A71457, A71460, A71461, A25285, A25288, A92060
  • Manufacturer
    Beckman Coulter Australia Pty Ltd
UniCel DxI Immunoassay Systems(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay ...
  • Model / Serial
    UniCel DxI Immunoassay Systems(Includes the UniCel DxI 600 and UniCel DxI 800 Access Immunoassay Systems; and the UniCel DxC 660i,UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i Synchron Access Clinical Systems)An in vitro diagnostic device (IVD)All Serial NumbersAll software versions
  • Manufacturer
    Beckman Coulter Australia Pty Ltd
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
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