OAX · Class II · 21 CFR 866.3402

FDA Product Code OAX: Plasmodium Spp. Detection Reagents

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.

Leading manufacturers include Inverness Medical Professional Diagnostics-Binax.

Total

Cleared

82d

Avg days

2007

Since

FDA 510(k) Cleared Plasmodium Spp. Detection Reagents Devices (Product Code OAX)

1 devices

1–1 of 1

Not Cleared Jun 13, 2007

BINAX NOW MALARIA TEST

DEN070006

Inverness Medical Professional Diagnostics-Binax

Microbiology · 82d

About Product Code OAX - Regulatory Context

Related FDA 510(k) Regulatory Insights

What is a Predicate Device in FDA 510(k)?
What is an FDA Product Code?
What is 510(k) Clearance?
Browse all Microbiology FDA 510(k) clearances
FDA 510(k) regulatory consulting firms ranked by submission volume
FDA 510(k) submission cost and user fees FY 2026

Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Jun 13, 2007

Product Code Info

Code	OAX
Device class	Class II
CFR	21 CFR 866.3402
Panel	Microbiology

Verify on FDA.gov

View OAX classification on FDA.gov →