Device Recall Alere iScreen Dx Urine Drug Screen Card

Manufacturer

  • Manufacturer Address
    Ameditech Inc, 9940 Mesa Rim Rd, San Diego CA 92121-2910
  • Source
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    P/N IS10-DX; Lot No. U0731
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
  • Product Description
    Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. || The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
  • Manufacturer