enGen(TM) Laboratory Automation Systems

  • Modèle / numéro de série
    All enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Chile, England, France, Germany, Italy, Mexico, Singapore and Spain.
  • Description du dispositif
    enGen(TM) Laboratory Automation Systems configured with Hettich Rotanta 46 RSC Robotic Centrifuges, Catalog # enGen -- Common/Usual Name: enGen(TM) Track System, Hettich Centrifuge -- Ortho-Clinical Diagnostics, Inc. Rochester, NY --- For in vitro diagnostic use only. || The VITROS 5,1 FS Chemistry System with enGen(TM) Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Ortho-Clinical Diagnostics, 100 Indigo Creek Drive, Rochester NY 14626
  • Source
    USFDA