Plasmodium Spp. Detection Reagents
The Plasmodium Spp. Detection Reagents (product code OAX) are in vitro diagnostic reagents used for the detection of Plasmodium species antigens in venous or capillary whole blood, aiding in the diagnosis of human malaria infections and the differential diagnosis of Plasmodium falciparum infections from other less virulent Plasmodium species. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.3402 within the Microbiology specialty. The device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAX
- Device Class
- FDA class 2
- Regulation Number
- 866.3402
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN070006 | BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX | Jun 13, 2007 | Unknown | Inverness Medical Professional Diagnostics-Binax |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.