# System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
> **Product code: PEX** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3361
## Classification
- **FDA Product Code:** PEX
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3361
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

## Market data
- **Cleared 510(k) submissions:** 5
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PEX)
---
*AI Analytics · CC0 1.0*