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BinaxNOW® Malaria

Alere Scarborough, Inc. · Model 665-025 · UDI-DI 10811877010378

OAX
1
510(k) clearances
5
Adverse events
0
Recalls
9
Facilities

Description

For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.

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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.