FDA Product Code PSU: Jak2 Gene Mutation Detection Test
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.
Leading manufacturers include Qiagen, Inc..
2
Total
1
Cleared
219d
Avg days
2017
Since
FDA 510(k) Cleared Jak2 Gene Mutation Detection Test Devices (Product Code PSU)
2 devices
Cleared
Jan 12, 2018
ipsogen JAK2 RGQ PCR Kit
Qiagen, Inc.
Pathology
168d
Not Cleared
Mar 27, 2017
ipsogen JAK2 RGQ PCR Kit
Qiagen, Inc.
Pathology
269d