OAX

Plasmodium Spp. Detection Reagents

Product code

OAX

Device name

Plasmodium Spp. Detection Reagents

Device class

Class 2

21 CFR

21 CFR 866.3402

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).