Plasmodium Spp. Detection Reagents Suppliers
www.invernessmedical.com | Send Inquiry | Phone: +1-(781)-647-3900
FDA Registration: 3004011380 Year Established: 2005 Annual Revenues: USD 25-50 Million Employee Count: ~180 Quality: CE Certified
Products: Ovulation (Luteinizing Hormone) Test Kits, Fertility Monitors, Pregnancy Test Kits, Home pregnancy test kits, Hcg, Pregnancy Test Kit, Human Chorionic Gonadotropin Test, Fertility Monitoring Test, ...
Inverness Medical Innovations, Inc. manufactures, markets & distributes agents for use in women's health, cardiology and infectious disease. We offer research, development and supply of professional d more...
A Plasmodium species antigen detection assay is a device that employs antibodies for the detection of specific malaria parasite antigens, including histidine-rich protein-2 (HRP2) specific antigens, and pan malarial antigens in human whole blood. These devices are used for testing specimens from individuals who have signs and symptoms consistent with malaria infection. The detection of these antigens aids in the clinical laboratory diagnosis of malaria caused by the four malaria species capable of infecting humans: Plasmodium falciparum , Plasmodium vivax , Plasmodium ovale , and Plasmodium malariae , and aids in the differential diagnosis of Plasmodium falciparum infections from other less virulent Plasmodium species. The device is intended for use in conjunction with other clinical laboratory findings.
Classification. Class II (special controls). The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Plasmodium species Antigen Detection Assays." See 866.1(e) for the availability of this guidance document.
