BioFire Diagnostics, LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 2 건

  • 모델명 / 제조번호(시리얼번호)
    RFIT-ASY-0126, RFIT-ASY-0127 | 440415, 442715, 447415, 447615, 448315, 454115, 458915, 459615, 462615, 470515, 400216, 400716, 403016, 403616, 405416, 407016, 407416, 410216, 412516 438115, 449515, 442815, 459715, 463115, 468015, 410016
  • 제품 설명
    IVD: Bloodstream infection-associated microorganism nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
  • 모델명 / 제조번호(시리얼번호)
    RFIT-ASY-0109, RFIT-ASY-0114 | all
  • 제품 설명
    IVD: Multiplex pathogen identification and resistance detection

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 9 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    BioFire Diagnostics, LLC, 515 S Colorow Dr, Salt Lake City UT 84108-1248
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 모회사 (2017)
  • 제조사 의견
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
하나 더 4 건 더