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| Product | Model | Company | Device type |
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| Product | Model | Company | Device type |
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The Alethia Malaria amplification assay, performed on the Alethia Incubator/Reader, is a qualitative in vitro diagnostic test 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 assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Plasmodium sp. DNA by targeting segments of the Plasmodium genome. Alethia Malaria assay does not distinguish between Plasmodium species.Alethia Malaria is intended for use in hospital, reference or state laboratory settings. The device is not intended for nonlaboratory point-of-care use.
| Product | Model | Company | Device type |
|---|---|---|---|
| Trinity BiotechClark Laboratories, Inc.Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) | 2322470 | Clark Laboratories, Inc. | Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) |
| Trinity BiotechClark Laboratories, Inc.Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) | 2322471 | Clark Laboratories, Inc. | Multiple Plasmodium species total antibody IVD, kit, enzyme immunoassay (EIA) |
| BinaxNOW® MalariaAlere Scarborough, Inc.Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical | 665-000 | Alere Scarborough, Inc. | Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical |
| Nano-CheckTM MalariaNano-Ditech CorporationMultiple Plasmodium species antigen IVD, kit, rapid ICT, clinical | MD8142 | Nano-Ditech Corporation | Multiple Plasmodium species antigen IVD, kit, rapid ICT, clinical |