Devices

Device Recall PLAC Test Reagent Kit

  • 모델명 / 제조번호(시리얼번호)
    All lot codes under recall.
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US, OUS: UK and Germany.
  • 제품 설명
    PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
  • Manufacturer
    DiaDexus, Inc
  • 1 Event

제조사

DiaDexus, Inc
  • 제조사 주소
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080-1913
  • 제조사 모회사 (2017)
    DiaDexus, Inc
  • Source
    USFDA