Device Recall QUANTIMETRIX URINALYSIS MICROSCOPICS CONTROL

  • Modèle / numéro de série
    Lot Number: 48170, 48171, 48172, 48180, 48181 and 48182.
  • 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 QuanTscopics Urine Microscopics Control. || QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is a bi-level control with stabilized human blood cells provide a means to validate the processing and is centrifugation of urine prior to microscopic analysis in compliance with CLIA regulations.
  • 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