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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
Regulation Description Plasmodium species antigen detection assays.
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

MDR Year MDR Reports MDR Events
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 2 2

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