De Novo DEN120014
- Device
- VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
- Contact
- mark del vecchio
- De Novo number
- DEN120014
- Product code
- PAM
- Regulation
- 866.3365
- Classification name
- gram-positive bacteria and their resistance markers
- Decision
- granted (DENG)
- Decision date
- 2012-06-26
- Date received
- 2012-06-15
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PAM
- Device name
- Gram-Positive Bacteria And Their Resistance Markers
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3365
- Implant
- N
- Life sustain/support
- N