OAX — Plasmodium Spp. Detection Reagents Class II
FDA product code OAX covers "Plasmodium Spp. Detection Reagents", a Class II medical device regulated under 21 CFR 866.3402. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OAX
- Device Class
- Class II
- Regulation Number
- 866.3402
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN070006 | inverness medical professional diagnostics-binax | BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX | June 13, 2007 |