Jak2 Gene Mutation Detection Test

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown