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Nano-CheckTM Dengue IgM/IgG

NANO-DITECH CORPORATION · Model MD8144 · UDI-DI 00895160002489

NWY
0
510(k) clearances
0
Adverse events
2
Recalls
6
Facilities

Description

An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.

Recalls

DateFirmReason
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,
2008-08-27Calbiotech IncThe recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall,

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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.