FDA-Device2022-02-09Class I
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Empowered Diagnostics LLC
Hazard
COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.
Sold states
US Nationwide Distribution
Affected count
284,575 units
Manufactured in
3341 W Mcnab Rd, N/A, Pompano Beach, FL, United States
Products
CovClear COVID-19 Rapid Antigen Test, ATG 900-031
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0480-2022Don't want to check this manually?
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