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PEO — Fungal Organisms, Nucleic Acid-Based Assay Class II

FDA Device Classification

Classification Details

Product Code
PEO
Device Class
Class II
Regulation Number
866.3365
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240627luminex corporationLIAISON PLEX Yeast Blood Culture AssayJune 4, 2024
K182690genmark diagnostics, incorporatedePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelDecember 21, 2018