DeviceClearance

Product code OAX— Microbiology

BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX

Classification name
Plasmodium Spp. Detection Reagents
Device class
Class 2
Regulation
21 CFR 866.3402
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OAX under 21 CFR 866.3402, via openFDA

Market context for product code OAX

FDA has cleared 1 device under product code OAX, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OAX

Recent clearances under product code OAX

Data sourced from openFDA. This site is unofficial and independent of the FDA.