PAM

Gram-Positive Bacteria And Their Resistance Markers

Product code

PAM

Device name

Gram-Positive Bacteria And Their 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

1 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant 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: 2026-08-06.

1 summaries are archived here for direct download.