OAX · Class II · 21 CFR 866.3402

FDA Product Code OAX: Plasmodium Spp. Detection Reagents

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.

1
Total
0
Cleared
82d
Avg days
2007
Since

FDA 510(k) Cleared Plasmodium Spp. Detection Reagents Devices (Product Code OAX)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OAX - Regulatory Context