Access Immunoassay Systems

  • Modelo / 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.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Descripción del producto
    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
  • 2 Events

Fabricante

  • Dirección del fabricante
    Beckman Coulter Inc., 250 S Kraemer Blvd, Brea CA 92821-6232
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

96 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot Numbers: 911748; 913265; 913500; 915417; 915850; and 916721
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and country of Canada.
  • Descripción del producto
    Access Immunoassay Systems enhanced AccuTnl Reagent Kit, Part Number: A78803 || The Access Accu Tri assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnl) levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and treatment of myocardial infarction and cardiac muscle damage. Cardiac Troponin I determination aids in the risk stratification of patients with unstable angina coronary syndromes with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events requiring urgent revascularization procedures.
  • Manufacturer
  • Modelo / Serial
    DxI System Software versions: 2.3, 2.4, 4.1, 4.2.1, 4.3 (Current released version), 4.3.2 (Released to a single Japanese customer only)
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Liechtenstein, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
  • Descripción del producto
    UniCel DxI 800 Access Immunoassay || Systems; Part Number(s): DxI 800: 973100, DxI 800 Remanufactured || A25288, DxI 800 with spot B A71456, DxI 800 || Reconditioned A25285 || The 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
  • Modelo / Serial
    Part Number: A54376, Synchron LXi 725 APF,  Lot Number: 722633, 823669. Part Number: A54377, Synchron LXi 725 AAF Lot Number: 722632, 823671.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Descripción del producto
    Access Immunoassay Systems Assay Protocol File (APF) Software versions for Synchron LXI 725. || Part Number: A54376, Synchron LXi 725 APF, || Part Number: A54377, Synchron LXi 725 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
  • Modelo / Serial
    Part Number: A54378, UniCel DxC 600i APF,  Lot Numbers: 722631, 823677. Part Number: A54379, UniCel DxC 600i AAF, Lot Numbers: 722630, 823675.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Descripción del producto
    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
  • Modelo / Serial
    Part Number 81901, Lot Numbers: 13181168-13341170.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, India, Hong Kong, Guatemala, China, Brazil, Brunei Darussalam, Costa Rica, El Salvador, JordanMalaysia, Mexico, Panama, Philippines, South Africa, Taiwan, Thailand, Trinidad and Tobago, United Arab Emirates, Venezuela, and Viet Nam.
  • Descripción del producto
    Access Immunoassay Systems Reaction Vessels. || The Access 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
91 más