De Novo DEN050004
- Device
- TAG-IT CYSTIC FIBROSIS KIT
- Contact
- nancy krunic
- De Novo number
- DEN050004
- Product code
- NUA
- Regulation
- 866.5900
- Classification name
- system, cystic fibrosis transmembrane conductance regulator, gene mutation detection
- Decision
- granted (DENG)
- Decision date
- 2005-05-09
- Date received
- 2005-04-05
- Classification advisory
- Immunology
- Review advisory
- Pathology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NUA
- Device name
- System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.5900
- Implant
- N
- Life sustain/support
- N