Device Recall InflammaDry

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 1705405, 1705359
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OK, PA, SC, SD, TX, VA, WA, & WV.
  • 제품 설명
    InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors || InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the MMP-9 protein in human tears, from patients suspected of having dry eye. InflammaDry is to be used to aid in the diagnosis of dry eye, in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Quidel Corporation, 10165 McKellar Ct, San Diego CA 92121-4201
  • 제조사 모회사 (2017)
  • Source
    USFDA