Product code PSU

Device name

Jak2 Gene Mutation Detection Test

Medical specialty

Medical Genetics

Device class

2

Regulation number

866.6070

Review panel

PA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset