PEOClass II
Fungal Organisms, Nucleic Acid-based Assay
Microbiology · 21 CFR 866.3365
A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.
MDR events5All time
Recalls0All time
Registered firms8Currently listed
510(k) clearances2All time
Recent MDR events
5 adverse event reports on file
- EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANELJan 13, 2026MalfunctionGenmark Diagnostics, Inc.3008632402-2026-00163
- EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANELJul 24, 2025MalfunctionGenmark Diagnostics, Inc.3008632402-2025-02245
- EPLEXMay 2, 2025MalfunctionGenmark Diagnostics, Inc.21949700
- EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANELNov 26, 2024MalfunctionGenmark Diagnostics, Inc.3008632402-2024-03436
- BCID2 PANELSep 14, 2023MalfunctionBiomerieux Sa/biofire Diagnostics, LlcMW5145662
Event type breakdown
Malfunction5
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
8 firms currently registered for this product code