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BinaxNOW® Malaria
For the qualitative detection of Plasmodium falciparum (P.f.) and pan-malarial antigens.
Details
Device typeMultiple Plasmodium species antigen IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from multiple species of Plasmodium, the malaria parasites (e.g., P. falciparum, P. vivax, P. ovale, P. knowlesi, P. malariae), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
FDA categoryPlasmodium Spp. Detection Reagents
Device ID10811877010361
Single useYes
MRI safetyLabeling does not contain MRI Safety Information