OAX
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Plasmodium Spp. Detection Reagents
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3402
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX (DEN070006) | Inverness Medical Professional Diagnostics-Binax | 2007-06-13 |
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