FDA-Device2022-05-18Class II
Diagnostic Kit SARS-cCo V Antigen Rapid Test
USA Medical, LLC
Hazard
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Sold states
U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
Affected count
2055 kits
Manufactured in
1220 Texan Trl Ste 205, N/A, Grapevine, TX, United States
Products
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1050-2022Don't want to check this manually?
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