De Novo DEN190016
- Device
- cobas vivoDx MRSA
- Contact
- nobuko nakajima
- De Novo number
- DEN190016
- Product code
- QIV
- Regulation
- 866.1655
- Classification name
- culture-based short-term incubation antimicrobial resistance assay
- Decision
- granted (DENG)
- Decision date
- 2019-12-05
- Date received
- 2019-03-19
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QIV
- Device name
- Culture-Based Short-Term Incubation Antimicrobial Resistance Assay
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.1655
- Implant
- N
- Life sustain/support
- N