Product code OAX

Device name

Plasmodium Spp. Detection Reagents

Medical specialty

Microbiology

Device class

2

Regulation number

866.3402

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset