Sekisui Diagnostics LLC

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 1 건

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania
  • 제품 설명
    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.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Sekisui Diagnostics Llc, 31 New York Ave, Framingham MA 01701-8860
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
  • 제조사 모회사 (2017)
  • Source
    USFDA