Device Recall OraQuick HCV Visual Reference Panel

  • Modèle / numéro de série
    Item Number 1001-0343, Lot # 6648737
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
  • Société-mère du fabricant (2017)
  • Source
    USFDA