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Nano-CheckTM Malaria

NANO-DITECH CORPORATION · Model MD8142 · UDI-DI 00895160002465

OAX
1
510(k) clearances
5
Adverse events
0
Recalls
9
Facilities

Description

An in vitro diagnostic test for the detection of malaria HRP2 (histidine-rich protein 2) of Plasmodium falciparum and pLDH (Plasmodium lactate dehydrogenase) of Plasmodium vivax in human whole blood as an aid in the diagnosis of malaria infection.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.