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Antigen, Galactomannan, Aspergillus Spp.

FDA product code NOM · Class 1 · Microbiology

5
Registered devices
1
Adverse events
2
Recalls
4
510(k) clearances

Devices with this code

Platelia — BIO-RADMycoMEIA Aspergillus Assay Sample Processing Columns — Pearl DiagnosticsMycoMEIA Aspergillus Assay 25X Concentrated Wash Solution — Pearl DiagnosticsMycoMEIA Aspergillus Assay — Pearl DiagnosticsMycoMEIA Aspergillus Assay Uncoated Plates — Pearl Diagnostics

Recent recalls

DateFirmReason
2005-01-25Bio Rad Laboratories, Inc.New instructions to recommend against using samples with visibly high level of blood.
2003-11-06Bio Rad Laboratories, Inc.Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.