Skip to contentDe Novo DEN210011
- Device
- Invitae Common Hereditary Cancers Panel
- Contact
- elaine cull
- De Novo number
- DEN210011
- Product code
- QVU
- Regulation
- 866.6095
- Classification name
- high throughput dna sequencing for hereditary cancer predisposition assessment test system.
- Decision
- granted (DENG)
- Decision date
- 2023-09-29
- Date received
- 2021-03-29
- Classification advisory
- Pathology
- Review advisory
- Molecular Genetics
- Type
- Direct
Current FDA Classification#
- Product code
- QVU
- Device name
- High Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.
- Medical specialty
- Pathology
- Device class
- 2
- Regulation
- 866.6095
- Implant
- N
- Life sustain/support
- N