DeviceClearance

Product code PEO— Microbiology

LIAISON PLEX Yeast Blood Culture Assay

Classification name
Fungal Organisms, Nucleic Acid-Based Assay
Device class
Class 2
Regulation
21 CFR 866.3365
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PEO under 21 CFR 866.3365, via openFDA

Market context for product code PEO

FDA has cleared 2 devices under product code PEO between 2018 and 2024, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PEO

Recent clearances under product code PEO

Data sourced from openFDA. This site is unofficial and independent of the FDA.