Access Immunoassay Systems

  • 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
  • 1 Event

Manufacturer

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

96 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers 824542 and 825652.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
  • Model / Serial
    Lot Numbers: 913016 (exp. 6/20/2010), 915171 (exp. 10/30/2010), 917766 (exp. 12/21/2010)
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and Internationally to: Algeria, Argentina, Armenia, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, El Salvador, France, Georgia, Germany, Ghana, Greece, India, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Oman, Panama, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab, United Kingdom, Venezuela, Vietnam, and Zambia
  • Product Description
    Access Immunoassay Systems Estradiol, Part Number: 33540 || Intended use: The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum and plasma using the Access Immunoassay systems.
  • Manufacturer
  • Model / Serial
    Lot Numbers: 911748; 913265; 913500; 915417; 915850; and 916721
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and country of Canada.
  • Product Description
    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
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