Access Immunoassay Systems

  • Modèle / numéro de série
    DxI software versions: 4.2 and 4.2.1. For labeling see UniCel DxI Operator's Guide. Part Number: 387262G
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States and Canada.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
  • Source
    USFDA

96 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Part Number: 386167; Lot Code: 1201291 & 1201431
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide & Canada
  • Description du dispositif
    UniCel Dxl Access Immunoassay Systems Reaction Vessels for Use with UniCel Dxl Access Immunoassay Systems, Part Number : 386167, Beckman Coulter, Inc, Brea CA 92822
  • Manufacturer
  • Modèle / numéro de série
    Part Number: 37215, Lot Number: 715293.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
  • Description du dispositif
    Beckman Coulter Access Hybritech free PSA Calibrators, REF 37215. || The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 715292 and 722462.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- Including states of AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OK, OR, PA, SC, TN, TX, VA, WI and WV.
  • Description du dispositif
    Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. || The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers 824542 and 825652.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Algeria, Angola, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, canada, Chile, China, Colombia, Czech Republic, Egypt, El Salvador, Ethiopia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Reunion, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Zambia.
  • Description du dispositif
    Access Immunoassay Systems Total ¿hCG. || The Access Total ¿hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total ¿hCG levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
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