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
  • 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
  • 1 Event

Manufacturer

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

96 devices with a similar name

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  • Model / Serial
  • Product Description
    Reagents - Clinical chemistry
  • Manufacturer
  • Model / Serial
    All Serial Numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
  • Model / Serial
    All Serial Numbers
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    UniCel DxI 800 Access Immunoassay Systems Part Numbers: 973100 || UniCel DxI 600 Access Immunoassay Systems Part Numbers: A30260 || UniCel DxC 600i, SYNCHRON Access Clinical Systems Part Numbers: A25656 || UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems Part Numbers: A64871, A64903, A64935, A59102 || Subsequent Product Codes: CEM || 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
  • Model / Serial
    All Lot Numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Access Myoglobin Reagents Kits, Part Number: 973243. || The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
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