Device Recall Bimerieux

  • 모델명 / 제조번호(시리얼번호)
    VITEK¿ 2 GP (ref: 21342):Lot Number 2420352403
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    International distribution.
  • 제품 설명
    The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms.
  • Manufacturer
  • 1 Event

제조사

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