PEO

Fungal Organisms, Nucleic Acid-Based Assay

Product code

PEO

Device name

Fungal Organisms, Nucleic Acid-Based Assay

Device class

Class 2

21 CFR

21 CFR 866.3365

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-06-04.

1 summaries are archived here for direct download.