Device Recall OraQuick HCV Visual Reference Panel

  • Modelo / Serial
    Item Number 1001-0343, Lot # 6648737
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.
  • Descripción del producto
    OraQuick HCV Visual Reference Panel || Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA