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HealthConfirm

CONFIRM BIOSCIENCES, INC. · Model COVIDRev061620 · UDI-DI 00856464008683

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by Clinical Reference Laboratory, Inc. located in Lenexa, KS. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.