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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plasmodium spp. detection reagents
Definition For the detection of plasmodium spp. Antigens in venous or capillary whole blood. To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent plasmodium species.
Product CodeOAX
Regulation Number 866.3402
Device Class 2

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