510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OAXClass II

Plasmodium Spp. Detection Reagents

21 CFR 866.3402 / Microbiology
FDA source (opens on fda.gov)

OAX is the FDA product code for Plasmodium Spp. Detection Reagents, a class II device type, regulated under 21 CFR 866.3402. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OAX
Device name
Plasmodium Spp. Detection Reagents
FDA 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.
Regulation
21 CFR 866.3402
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OAX

By decision year
1 clearance under product code OAX with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OAX by decision year
YearClearances
20071

Applicants with the most clearances

Product code OAX
Applicants holding the most 510(k) clearances under product code OAX
ApplicantClearances
Inverness Medical Professional Diagnostics-Binax1

Companies listing this code with FDA

Companies whose registered establishments list this code