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Diamedix

DIAMEDIX CORPORATION · Model 720-640 · UDI-DI 00817273020358

GNP
1
510(k) clearances
0
Adverse events
2
Recalls
4
Facilities

Description

"720-640 EBV-EA-D IgG Test Kit"

Recalls

DateFirmReason
2018-01-05Diamedix CorporationContains a gel-like contaminant that may affect product performance.
2014-10-20Diamedix CorporationA gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance.

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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.