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Alethia Malaria PLUS

MERIDIAN BIOSCIENCE, INC. · Model 481125 · UDI-DI 00840733102257

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Description

The Alethia Malaria PLUS DNA amplification assays, performed on the Alethia Incubator/Reader, are qualitative in vitro diagnostic tests for the direct detection of Plasmodium sp. DNA in human venous EDTA whole blood specimens from individuals with signs and symptoms of malarial infection. Results from Alethia Malaria assays are intended to be used as an aid in the diagnosis of human malaria infection. Alethia Malaria assays utilize loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assays do not distinguish between Plasmodium species. Alethia Malaria PLUS is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.

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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.