De Novo DEN150013
- Device
- FilmArray Meningitis/Encephalitis(ME) Panel
- Contact
- kristen j kanack
- De Novo number
- DEN150013
- Product code
- PLO
- Regulation
- 866.3970
- Classification name
- meningitis/encephalitis pathogen multiplex nucleic acid detection system
- Decision
- granted (DENG)
- Decision date
- 2015-10-08
- Date received
- 2015-04-09
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PLO
- Device name
- Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3970
- Implant
- N
- Life sustain/support
- N