PEN

Gram-Negative Bacteria And Associated Resistance Markers

Product code

PEN

Device name

Gram-Negative Bacteria And Associated Resistance Markers

Device class

Class 2

21 CFR

21 CFR 866.3365

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers 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 (2)

Last three years. Most recent: 2025-04-18.

2 summaries are archived here for direct download.