Factor II (prothrombin) G20210A 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 II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis, IN || The Factor II (prothrombin) G20210A kit allows the detection and genotyping of a single point mutation (G to A at position 20210) of the human factor II gene, 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 II DNA recovered from clinical samples snd fluorigenic target-specific hybridization for the detection and genotyping of the amplified Factor II DNA. The Factor II (prothrombin) G20210A test is an in vitro diagnostic test for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation as an aide to dignosis 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