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De Novo DEN070006
- Device
- BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX
- Contact
- anne jepson
- De Novo number
- DEN070006
- Product code
- OAX
- Regulation
- 866.3402
- Classification name
- plasmodium spp. detection reagents
- Decision
- granted (DENG)
- Decision date
- 2007-06-13
- Date received
- 2007-03-23
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OAX
- Device name
- Plasmodium Spp. Detection Reagents
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3402
- Implant
- N
- Life sustain/support
- N