De Novo DEN160003
- Device
- Quantidex qPCR BCR-ABL IS Kit
- Contact
- fayyaz memon
- De Novo number
- DEN160003
- Product code
- OYX
- Regulation
- 866.6060
- Classification name
- bcr/abl1 monitoring test
- Decision
- granted (DENG)
- Decision date
- 2016-07-22
- Date received
- 2016-01-19
- Classification advisory
- Molecular Genetics
- Review advisory
- Molecular Genetics
- Type
- Direct
Current FDA Classification#
- Product code
- OYX
- Device name
- Bcr/Abl1 Monitoring Test
- Medical specialty
- Medical Genetics
- Device class
- 2
- Regulation
- 866.6060
- Implant
- N
- Life sustain/support
- N