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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State In Vitro diagnostic kit
Technical Method In vitro diagnostic immunochromatographic membrane assays or lateral flow assays that uses antibodies to detect specific antigens.
Target Area Plasmodium spp. antigens in whole blood
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOAX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3402
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm092765.htm] 
Third Party Review Not Third Party Eligible
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