Plasmodium Spp. Detection Reagents
Microbiology · 21 CFR 866.3402
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 MDR events
5 adverse event reports on file
- BINAXNOW MALARIA 25T USMar 25, 2026MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2026-00037
- BINAXNOW MALARIA 25T USMar 25, 2026MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2026-00038
- BINAXNOW MALARIA 25T USMar 25, 2026MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2026-00036
- BINAXNOW MALARIA 25T OUSJan 12, 2026MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2026-00007
- BINAXNOW MALARIA 25T OUSJan 12, 2026MalfunctionAbbott Diagnostics Scarborough, Inc.1221359-2026-00008
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Acro Biotech Inc.
Montclair, CA, US
Abbott Diagnostics Scarborough, Inc.
Westbrook, ME, US
Access Bio, Inc.
Monroe Township, NJ, US
Premier Medical Usa Corporation
Somerset, NJ, US
Trinity Biotech Usa
Jamestown, NY, US
Abbott Diagnostics Scarborough, Inc.
Scarborough, ME, US
Premier Medical Corporation Private Limited
VALSAD Gujarat, IN
Ctk Biotech, Inc.
Poway, CA, US
Boston Easy Biotech Inc
Andover, MA, US
510(k) clearances
1 clearances for this product code