Device Recall VIDAS Estradiol II (E2 II)

  • 모델명 / 제조번호(시리얼번호)
    Lots 1005081700, 1005172850 & 1005359170
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AZ, CA, CO, FL, GA, IN, IA, LA, MI, MS, NY, NC, OH, OK, OR, PA, TX, WA
  • 제품 설명
    VIDAS Estradiol II, Ref 30431-01, 60 tests || The VIDAS Estradiol II (E2 II) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated quantitative enzyme-linked fluorescent immunoassay (ELFA) to the determination of total estradiol concentration in human serum or plasma (heparin).
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    BioMerieux SA, Chemin De L'Orme, Marcy L'Etoile France
  • 제조사 모회사 (2017)
  • Source
    USFDA