FDA-Device2017-09-06Class III
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
Ameditech Inc
Hazard
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
Sold states
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Affected count
263Kits
Manufactured in
9940 Mesa Rim Rd, N/A, San Diego, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3084-2017Don't want to check this manually?
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