BioFire Diagnostics, LLC

2 devices in the database

  • Model / Serial
    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
  • Product Description
    IVD: Bloodstream infection-associated microorganism nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
  • Model / Serial
    RFIT-ASY-0109, RFIT-ASY-0114 | all
  • Product Description
    IVD: Multiplex pathogen identification and resistance detection

9 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    BioFire Diagnostics, LLC, 515 S Colorow Dr, Salt Lake City UT 84108-1248
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    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
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