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Diamedix
DIAMEDIX CORPORATION · Model 720-640 · UDI-DI 00817273020358
1
510(k) clearances
0
Adverse events
2
Recalls
4
Facilities
Description
"720-640 EBV-EA-D IgG Test Kit"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-01-05 | Diamedix Corporation | Contains a gel-like contaminant that may affect product performance. |
| 2014-10-20 | Diamedix Corporation | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
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Get your free API keyRead the docsData 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.
