Sekisui Diagnostics LLC

Un dispositivo en la base de datos

  • Modelo / Serial
    The following are part numbers and lot number combinations.  PN:173E, LN:121272. PN:173, LN:121273. PN:173, LN:121273A. PN:173E, LN:131155. PN:173, LN:131156.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania
  • Descripción del producto
    Product Name: OSOM C. Difficile Toxin A/B Test || Catalog Numbers: 173 (for United States) and 173 E (for Europe). || The Test is a qualitative assay (in vitro diagnostic) that employs || immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears || The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.

3 fabricantes con un nombre similar

Más información acerca de la data acá

  • Dirección del fabricante
    Sekisui Diagnostics Llc, 31 New York Ave, Framingham MA 01701-8860
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA