Roche/Hitachi cobas ONLINE TDM Gentamicin

  • Model / Serial
    Lot Numbers 15622600, 15617800, 15616900 and 15816200.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers 15617800, 15622600, 15616900 and 15621900.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
  • Manufacturer