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NEW YORK ─ The US Food and Drug Administration has issued a warning letter to KBMO Diagnostics, demanding that the firm cease selling an unapproved, uncleared, and unauthorized product for mitigation, prevention, treatment, or diagnosis of COVID-19.

KBMO's website states that its product uses at-home blood sample collection for COVID-19 serology testing, the FDA said in a warning letter to the firm dated June 17.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.