Device Recall Pacific Hemostasis Fibrinogen Degradation Products

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 948546, Exp. 9/30/2017
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA (nationwide) including Puerto Rico, and Internationally to Colombia
  • 제품 설명
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Fisher Diagnostics, 8365 Valley Pike, Middletown VA 22645-1905
  • Source
    USFDA