De Novo DEN140019
- Device
- T2CANDIDA AND T2DX INSTRUMENT
- Contact
- sarah kalil
- De Novo number
- DEN140019
- Product code
- PII
- Regulation
- 866.3960
- Classification name
- candida species nucleic acid detection system
- Decision
- granted (DENG)
- Decision date
- 2014-09-22
- Date received
- 2014-05-27
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PII
- Device name
- Candida Species Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3960
- Implant
- N
- Life sustain/support
- N