# Gram-Negative Bacteria And Associated Resistance Markers
> **Product code: PEN** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3365
## Classification
- **FDA Product Code:** PEN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3365
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

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

## Market data
- **Cleared 510(k) submissions:** 11
- **Registered establishments:** 4
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PEN)
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