QMS Everolimus Assay

  • Modèle / numéro de série
    Lot number: 72258049, Expiry date: 07/31/2017; Lot number: 72258007, Expiry date 07/31/2017.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of KY, CA, NY, DC, NC, TX, IL, OH, IL, FL, IK, IA, MS and countries of Mexico, Taiwan, Guatemala, Malaysia, Argentina, Dominican Republic, Philippines, Germany, Australia.
  • Description du dispositif
    Thermo Scientific QMS Everolimus Assay; || Model number: || 0380000 (US Distribution); || 0373852 (Foreign Distribution) || Product Usage: || The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Microgenics Corporation, 46500 Kato Rd, Fremont CA 94538-7310
  • Société-mère du fabricant (2017)
  • Source
    USFDA

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