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Jak2 Gene Mutation Detection Test

FDA product code PSU · 1 cleared devices

Class 2 Medical Genetics
Regulation
21 CFR 866.6070
Review panel
PA
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2018-01-12 – 2018-01-12

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.

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