PSUClass II
Jak2 Gene Mutation Detection Test
Medical Genetics · 21 CFR 866.6070
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.
MDR events1All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances2All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Unspecified1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
2 clearances for this product code