Jak2 Gene Mutation Detection Test
FDA product code PSU · Class II (moderate risk) · 21 CFR 866.6070 · Medical Genetics
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.
1510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172287 | ipsogen JAK2 RGQ PCR KitPSU · Traditional | Qiagen, Inc. | 01/12/2018SE |