Device Recall BD CD8 (SK1) phycoerythrin (PE)

  • 모델명 / 제조번호(시리얼번호)
    Lot number 4220622, Expiry 2016-04-30.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. US Nationwide including Puerto Rico, China, Brazil, Japan, Guatemala, India, New Zealand, Australia, Canada, Thailand, Chile and Malaysia.
  • 제품 설명
    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. || Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    BD Biosciences, Systems & Reagents, 2350 Qume Dr, San Jose CA 95131-1812
  • 제조사 모회사 (2017)
  • Source
    USFDA