FDA-Device2014-12-31Class II
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Unistrip Technologies LLC
Hazard
Failure to submit a 510(k) for device labeling changes.
Sold states
US Distribution to the states of FL and OH.
Affected count
7175 units
Manufactured in
301 Mccullough Dr, Suite 400, Charlotte, NC, United States
Products
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0855-2015Don't want to check this manually?
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