FDA-Device2022-01-05Class II
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Migo Trading LLC
Hazard
Devices are determined to be inconsistent with the firm's Emergency Use Authorization (EUA). This product has not been authorized for emergency use and the test cannot be determined to be adequately validated for the stated intended use.
Sold states
NY
Affected count
200,100 units
Manufactured in
831 Laca St, Dayton, NV, United States
Products
FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0421-2022Don't want to check this manually?
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