Device Recall Access Thyroglobulin Antibody II, Part Number: A32898

  • 모델명 / 제조번호(시리얼번호)
    Lot Number:  012741, 014751, 016551, 016838
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AR, CA, FL, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI and the countries of Argentina, Armenia, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, French Polynesia, Georgia, Germany, Greece, Hungary, Israel, Italy, Kazakhstan, Kuwait, Lebanon, Morocco, Netherlands, New Zealand, Oman, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Spain, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Arab Emirates, Yemen
  • 제품 설명
    Access Thyroglobulin Antibody II, Part Number: A32898 || The Access Thyroglobulin Antibody II (TgAb) assay intended use is for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
  • 1 Event

제조사

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