Devices

Device Recall InflammaDry

  • Modèle / numéro de série
    Lot numbers: 1705405, 1705359
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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
    Quidel Corporation
  • 1 Event

Fabricant

Quidel Corporation
  • Adresse du fabricant
    Quidel Corporation, 10165 McKellar Ct, San Diego CA 92121-4201
  • Société-mère du fabricant (2017)
    Quidel Corporation
  • Source
    USFDA