De Novo DEN160028
- Device
- ipsogen JAK2 RGQ PCR Kit
- Contact
- lindsey howard
- De Novo number
- DEN160028
- Product code
- PSU
- Regulation
- 866.6070
- Classification name
- jak2 gene mutation detection test
- Decision
- granted (DENG)
- Decision date
- 2017-03-27
- Date received
- 2016-07-01
- Classification advisory
- Molecular Genetics
- Review advisory
- Pathology
- Type
- Direct
Current FDA Classification#
- Product code
- PSU
- Device name
- Jak2 Gene Mutation Detection Test
- Medical specialty
- Medical Genetics
- Device class
- 2
- Regulation
- 866.6070
- Implant
- N
- Life sustain/support
- N