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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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