# Jak2 Gene Mutation Detection Test
> **Product code: PSU** · Class II — Moderate Risk (510(k) clearance required) · Medical Genetics · 21 CFR 866.6070
## Classification
- **FDA Product Code:** PSU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.6070
- **Review panel:** PA
- **Medical specialty:** Medical Genetics
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene.  It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PSU)
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