De Novo DEN100020
- Device
- DENV DETECT IGM CAPTURE ELISA
- Contact
- estela i raychaudhuri
- De Novo number
- DEN100020
- Product code
- OSU
- Regulation
- 866.3945
- Classification name
- dengue serological reagents
- Decision
- granted (DENG)
- Decision date
- 2011-04-08
- Date received
- 2010-10-20
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OSU
- Device name
- Dengue Serological Reagents
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3945
- Implant
- N
- Life sustain/support
- N