Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The COVID-19 Test Kits are offered for sale directly to consumers for at-home testing or distributed in the United States without marketing approval, clearance, or authorization from FDA.
Passage 2your website represents that these products are “FDA Approved” or “FDA Authorized.” These representations create a false impression that your products have been approved or authorized for emergency use by FDA and are misleading.