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Plasmodium Spp. Detection Reagents

Plasmodium Spp. Detection Reagents is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
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Plasmodium Spp. Detection Reagents
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OAX

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Class 2

21 CFR 866.3402

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Microbiology

Device Characteristics

No

No

No

Not Eligible

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.