# Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
> **Product code: PMN** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3920
## Classification
- **FDA Product Code:** PMN
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3920
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## Definition

Assayed external quality control material to monitor the performance of microbiology nucleic acid assays for in vitro diagnostic use.

## Market data
- **Cleared 510(k) submissions:** 30
- **Registered establishments:** 10
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PMN)
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