De Novo DEN160001
- Device
- BD MAX Vaginal Panel, BD MAX Instrument
- Contact
- manon richard
- De Novo number
- DEN160001
- Product code
- PQA
- Regulation
- 866.3975
- Classification name
- vaginitis and bacterial vaginosis nucleic acid detection system
- Decision
- granted (DENG)
- Decision date
- 2016-10-28
- Date received
- 2016-01-11
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PQA
- Device name
- Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3975
- Implant
- N
- Life sustain/support
- N