Factor V Leiden kit

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: AL, AZ, CA, CO, DC, FL, GA, HI, IL, KY, LA, MA, MD, ME, MN, MO, MT, NC, ND NE, NH, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, VT, WI and Puerto Rico; and country of Europe.
  • Description du dispositif
    Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN || The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection of genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler 2.0 Instrument using the LightCycler Software 4.05 or 4.1.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Road, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
  • Source
    USFDA

8 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
  • Description du dispositif
    In-vitro diagnostics
  • Manufacturer
  • Modèle / numéro de série
    Lot Number Expiration 12659020 30-Sep-2007 13014720 31-Jan-2008 13368720 31-Jul-2008 13368820 31-Jul-2008 13462420 30-Sep-2008 13749620 31-Jan-2009 13793120 31-Jan-2009 14066220 31-May-2009 14447220 30-Jun-2009 14172920 30-Sep-2009 14692620 31-Dec-2009 14692621 31-Dec-2009 10964020 30-Sep-2010 11242120 31-Jan-2011 11666730 31-May-2011 11965420 30-Sep-2011 12180320 31-Dec-2011 12433020 30-Apr-2012
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 03610179001. || For use with Light Cycler 2.0 instrument; The Factor V Leiden Kit allows the detection and genotyping of a single point mutation (G to A at position 1691) of the human Factor V gene, referred to as Factor V Leiden mutation, from DNA isolated from human whole peripheral blood. The test is performed on the LightCycler¿ 2.0 Instrument utilizing polymerase chain reaction (PCR) for the amplification of Factor V DNA recovered from clinical specimens and fluorogenic target-specific hybridization for the detection and genotyping of the amplified Factor V DNA. The Factor V Leiden test is an in vitro diagnostic test for the detection and genotyping of the Factor V Leiden mutation as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The test is intended to be used on the LightCycler¿ 2.0 Instrument using the LightCycler¿ Software 4.05 or 4.1. The specimen preparation must be performed according to the workflow procedures described in the package insert.
  • Manufacturer
  • Modèle / numéro de série
    3610179001 | 14674120
  • Description du dispositif
    IVD: Genetic Testing: Factor V Leiden
  • Manufacturer
  • Modèle / numéro de série
    13560320
  • Description du dispositif
    IVD: Genetic Testing - Factor V Leiden
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 03610179001 (Lot serial: 13560320)
  • Description du dispositif
    Factor V Leiden Kit/LightCycler V2.0
  • Manufacturer
3 en plus