OSOM C. Difficile Toxin A/B Test

  • Model / 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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sekisui Diagnostics LLC, 6659 Top Gun St, San Diego CA 92121-4113
  • Manufacturer Parent Company (2017)
  • Source
    USFDA