Devices

Device Recall OraQuick HCV Visual Reference Panel

  • Model / Serial
    Item Number 1001-0343, Lot # 6648737
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    3
  • Implanted device?
    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.
  • Product Description
    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
    OraSure Technologies, Inc.
  • 1 Event

Manufacturer

OraSure Technologies, Inc.
  • Manufacturer Address
    OraSure Technologies, Inc., 1745 Eaton Ave, Bethlehem PA 18018-1769
  • Manufacturer Parent Company (2017)
    OraSure Technologies, Inc.
  • Source
    USFDA