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MycoMEIA Aspergillus Assay Uncoated Plates
Pearl Diagnostics · Model 25101 · UDI-DI 00860009979574
NOM
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
3
Facilities
Description
The MycoMEIA® Aspergillus Assay (MycoMEIA) is a sandwich enzyme immunoassay (EIA) that detects Aspergillus antigens in urine. The assay uses two mouse monoclonal antibodies that recognize galactofuranose (galf) epitopes. Both monoclonal antibodies are used to coat the wells of the microplate to bind the antigen, and to detect the antigen bound to the sensitized microplate as horseradish-peroxidase conjugates. Uncoated plates are used to fill in empty spaces if a partial assay plate is being used.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2005-01-25 | Bio Rad Laboratories, Inc. | New instructions to recommend against using samples with visibly high level of blood. |
| 2003-11-06 | Bio Rad Laboratories, Inc. | Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan. |
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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.