PSU

Jak2 Gene Mutation Detection Test

Product code

PSU

Device name

Jak2 Gene Mutation Detection Test

Device class

Class 2

21 CFR

21 CFR 866.6070

Medical specialty

Medical Genetics

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).