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BinaxNOW COVID-19/Flu A&B Combo Self Test

Alere Scarborough, Inc. · Model 295-361 · UDI-DI 00811877012115

SCA
10
510(k) clearances
51
Adverse events
0
Recalls
26
Facilities

Description

Intended for detection of proteins from Influenza A, Influenza B and SARS-CoV-2, not for any other viruses or pathogens - display

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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.