Antigen, Galactomannan, Aspergillus Spp.
Microbiology · 21 CFR 866.3040
The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in human serum. It is a test which, when used in conjunction with other diagnostic procedures such as microbiological culture, histological examination of biopsy samples and radiographic evidence, can be used as an aid in the diagnosis of Invasive Aspergillosis.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- Bio Rad Laboratories, Inc.TerminatedMar 29, 2005
Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATHFINDER RSV DIRECT ANTIGEN DETECTION SYSTEM 79674 IN VITRO TEST DIAGNOSTIC USE Distributed in the U.
New instructions to recommend against using samples with visibly high level of blood.
Z-0659-05 · View FDA record ↗ - Bio Rad Laboratories, Inc.TerminatedJan 14, 2004
Platelia Aspergillus EIA
Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
Z-0348-04 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
4 clearances for this product code