De Novo DEN170017
- Device
- FilmArray Respiratory Panel 2 plus (RP2plus)
- Contact
- kristen j. kanack
- De Novo number
- DEN170017
- Product code
- PZF
- Regulation
- 866.4001
- Classification name
- mers-cov and common respiratory pathogens multiplex nucleic acid detection system
- Decision
- granted (DENG)
- Decision date
- 2017-11-24
- Date received
- 2017-03-16
- Classification advisory
- Pathology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PZF
- Device name
- Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System
- Medical specialty
- Pathology
- Device class
- 2
- Regulation
- 866.4001
- Implant
- N
- Life sustain/support
- N