COBAS AmpliPrep / COBAS TaqMan HCV

Fabricant

2 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    03568555190; All lots; all expirys
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) and countries of: Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudia Arabia, Sinagpore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • Description du dispositif
    COBAS¿ AmpliPrep / COBAS¿ TaqMan¿ HCV Test, US-IVD || The COBAS¿ AmpliPrep/COBAS¿ TaqMan¿ HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA in human plasma or serum of HCV-infected individuals using the COBAS¿ AmpliPrep Instrument for automated specimen processing and the COBAS¿ TaqMan¿ Analyzer or the COBAS¿ TaqMan¿ 48 Analyzer for automated amplification and detection. Specimens containing HCV genotypes 1 6 have been validated for quantitation in the assay. The COBAS AmpliPrep/COBAS TaqMan HCV Test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy.
  • Manufacturer
  • Modèle / numéro de série
    03568547190; All lots
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    USA (nationwide) and countries of: Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudia Arabia, Sinagpore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • Description du dispositif
    COBAS¿ AmpliPrep / COBAS¿ TaqMan¿ HCV Test, CE-IVD || The COBAS¿ AmpliPrep/COBAS¿ TaqMan¿ HCV Test is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C Virus (HCV) RNA in human plasma or serum using the COBAS¿ AmpliPrep Instrument for automated specimen processing and the COBAS¿ TaqMan¿ Analyzer or the COBAS¿ TaqMan¿ 48 Analyzer for automated amplification and detection. The Test is intended for use in conjunction with clinical presentation and other laboratory markers of HCV infection for the clinical management of patients with chronic HCV.
  • Manufacturer