FDA-Device2022-02-09Class I
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
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
2100 units
Manufactured in
3341 W Mcnab Rd, N/A, Pompano Beach, FL, United States
Products
ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0481-2022Don't want to check this manually?
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