Device Recall QUANTIMETRIX URINE DIPSTICK CONTROL

  • Modèle / numéro de série
    Lot Numbers: 47160, 47170, 47180, 47190, 47200 and 47210.
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including states of AK, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, NC, ND, NH, NM, NY, OR, PA, SC, SD, TN, TX, VA, WA and WY.
  • Description du dispositif
    Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. || The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Quantimetrix Corporation, 2005 Manhattan Beach Blvd, Redondo Beach CA 90278-1205
  • Société-mère du fabricant (2017)
  • Source
    USFDA