BD GeneOhm Cdiff Assay

  • Modelo / Serial
    Lot 08T13108 Exp Dec 24 2013
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
  • Descripción del producto
    BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** || The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Becton Dickinson & Co., BD Diagnostic Systems, 7 Loveton Circle, Sparks MD 21152-0999
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA

3 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot/ Exp. 08T11250 2012-07-06
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including CA, DE, FL, GA, IL, IN, KS, KY, ME, MT, NC, NJ, NM, NY, OH, OK, PA, SC, TX, VA, WA, WI, and WV.
  • Descripción del producto
    BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** || BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. The test is performed directly on the specimen, utilizing polymerase chain reaction (PCR) for the amplification of specific targets and fluorogenic target-specific hybridization probes for the detection of the amplified DNA.
  • Manufacturer
  • Modelo / Serial
    441400 | 08T11251
  • Descripción del producto
    IVD: Clostridium difficile toxin A/B nucleic acid IVD, kit, nucleic acid technique (NAT); DNA-probe, Staph aureus; Vancomycin kit
  • Manufacturer
  • Modelo / Serial
    Lot/Exp date: 08T09101 2010-06-30 08T09101A 2010-06-30 08T09103 2010-07-02
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- IL, IN, PA, WA, CA, VA, NJ, and KS.
  • Descripción del producto
    BD GeneOhm Cdiff Assay, Catalog 441401, 200 tests/kit, labeled, in part ***BD Diagnostics, 2555 Boul. Du Parc-Technologique, Quebec, Canada G1P4S5*** || Intended for use as an aid in diagnosis of CDAD.
  • Manufacturer