De Novo DEN180014
- Device
- WOUNDCHEK Bacterial Status
- Contact
- angela drysdale
- De Novo number
- DEN180014
- Product code
- QFA
- Regulation
- 866.3231
- Classification name
- assay for detection of proteases in chronic wounds
- Decision
- granted (DENG)
- Decision date
- 2019-12-02
- Date received
- 2018-03-23
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QFA
- Device name
- Assay For Detection Of Proteases In Chronic Wounds
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3231
- Implant
- N
- Life sustain/support
- N