Device Recall Access Total T4 Reagent Kit

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers (s): All reagent pack lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Argentina Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Egypt, El Salvador, Ethiopia, France, Germany, Greece, Guatemala, Hong Kong, India, Israel, Italy, Japan, Jordan, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Malaysia, Mexico, Republic of Moldova, Morocco, Myanmar, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Philippines, Poland, Puerto Rico, Reunion, Romania, Russian Federation, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, Yemen, and Zambia
  • 제품 설명
    Access Total T4 Reagent Kit, Part Number: 33800, || Lot Numbers (s): All reagent pack lots || The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • 제조사 모회사 (2017)
  • Source
    USFDA