# Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
> **Product code: PRE** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215
## Classification
- **FDA Product Code:** PRE
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.3215
- **Review panel:** MI
- **Medical specialty:** Microbiology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood.

## Market data
- **Cleared 510(k) submissions:** 4
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PRE)
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