De Novo DEN030002
- Device
- ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE
- Contact
- tom tsakeris
- De Novo number
- DEN030002
- Product code
- NGS
- Regulation
- 866.3210
- Classification name
- assay, endotoxin activity, chemiluminescent
- Decision
- granted (DENG)
- Decision date
- 2003-06-16
- Date received
- 2003-04-14
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NGS
- Device name
- Assay, Endotoxin Activity, Chemiluminescent
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3210
- Implant
- N
- Life sustain/support
- N