FDA Product Code PEO: Fungal Organisms, Nucleic Acid-based Assay
A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Fungal Organisms In Positive Blood Cultures.
Leading manufacturers include Genmark Diagnostics, Incorporated and Luminex Corporation.
2
Total
2
Cleared
88d
Avg days
2018
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Fungal Organisms, Nucleic Acid-based Assay Devices (Product Code PEO)
2 devices
Cleared
Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
Luminex Corporation
Microbiology
90d
Cleared
Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
Genmark Diagnostics, Incorporated
Microbiology
85d
About Product Code PEO - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code PEO since 2018, with 2 receiving FDA clearance (average review time: 88 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.