De Novo DEN230046
- Device
- PGDx elio plasma focus Dx
- Contact
- jennifer dickey
- De Novo number
- DEN230046
- Product code
- SBY
- Regulation
- 866.6085
- Classification name
- high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids
- Decision
- granted (DENG)
- Decision date
- 2024-08-01
- Date received
- 2023-06-30
- Classification advisory
- Pathology
- Review advisory
- Pathology
- Type
- Direct
Current FDA Classification#
- Product code
- SBY
- Device name
- High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
- Medical specialty
- Pathology
- Device class
- 2
- Regulation
- 866.6085
- Implant
- N
- Life sustain/support
- N