PEN

11 FDA 510(k) clearances · Product code

FDA profile

Official device name

Gram-Negative Bacteria And Associated Resistance Markers

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3365

Medical specialty

Microbiology

FDA definition

A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.

Adverse events (MAUDE)

2021: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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