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Plasmodium Spp. Detection Reagents

FDA product code OAX · Class 2 · Microbiology

11

Registered devices

5

Adverse events

0

Recalls

1

510(k) clearances

Devices with this code

Bio-Rad — CLARK LABORATORIES, INC.BinaxNOW® Malaria — Alere Scarborough, Inc.Trinity Biotech — CLARK LABORATORIES, INC.BinaxNOW® Malaria — Alere Scarborough, Inc.Alethia Malaria External Control Kit — MERIDIAN BIOSCIENCE, INC.Alethia Malaria PLUS — MERIDIAN BIOSCIENCE, INC.Nano-CheckTM Malaria — NANO-DITECH CORPORATION Trinity Biotech — CLARK LABORATORIES, INC.Alethia Malaria — MERIDIAN BIOSCIENCE, INC.Trinity Biotech — CLARK LABORATORIES, INC.Bio-Rad — CLARK LABORATORIES, INC.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.