510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
PSUClass II

Jak2 Gene Mutation Detection Test

21 CFR 866.6070 / Medical Genetics
FDA source (opens on fda.gov)

PSU is the FDA product code for Jak2 Gene Mutation Detection Test, a class II device type, regulated under 21 CFR 866.6070. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PSU
Device name
Jak2 Gene Mutation Detection Test
FDA 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.
Regulation
21 CFR 866.6070
Device class
Class II
Review panel
Medical Genetics
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PSU

By decision year
2 clearances under product code PSU with a decision year between 2017 and 2018, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PSU by decision year
YearClearances
20171
20181

Applicants with the most clearances

Product code PSU
Applicants holding the most 510(k) clearances under product code PSU
ApplicantClearances
Qiagen2

Companies listing this code with FDA

Companies whose registered establishments list this code