Plasmodium Spp. Detection Reagents

OAX · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3402

Classification

FDA Product Code: OAX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3402
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 9

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown