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De Novo DEN120012
- Device
- CDC DENV-1-4 REAL TIME RT-PCT ASSAY
- Contact
- hye-joo kim
- De Novo number
- DEN120012
- Product code
- OZB
- Regulation
- 866.3946
- Classification name
- dengue nucleic acid amplification assay (naat)
- Decision
- granted (DENG)
- Decision date
- 2012-05-24
- Date received
- 2012-03-12
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OZB
- Device name
- Dengue Nucleic Acid Amplification Assay (Naat)
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3946
- Implant
- N
- Life sustain/support
- N