PSU
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Jak2 Gene Mutation Detection Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6070
- Medical specialty
- Medical Genetics
- 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.
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| Record | Firm | Date |
|---|---|---|
| ipsogen JAK2 RGQ PCR Kit (K172287) | Qiagen, Inc. | 2018-01-12 |
| ipsogen JAK2 RGQ PCR Kit (DEN160028) | Qiagen, Inc. | 2017-03-27 |
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Every clearance here is in the API, with alerts when new ones post.