FDA product code OAX: Plasmodium Spp. Detection Reagents
OAX is the FDA product code for plasmodium spp. detection reagents. It is a Class II device, regulated under 21 CFR 866.3402 and reviewed by the Microbiology panel. Devices under OAX reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Plasmodium Spp. Detection Reagents |
| Device class | Class II |
| Regulation | 21 CFR 866.3402 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
Recalls for OAX devices
openFDA lists no recalls for product code OAX.
Frequently asked questions
What is FDA product code OAX?
OAX is the FDA product code for plasmodium spp. detection reagents. It is a Class II device, regulated under 21 CFR 866.3402 and reviewed by the Microbiology panel.
What device class is OAX?
Class II, regulation 21 CFR 866.3402. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OAX
- Run a recall and safety report across every OAX manufacturer
- Watch product code OAX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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