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De Novo DEN160016
- Device
- Variola virus Real-Time PCR Assay
- Contact
- yon yu
- De Novo number
- DEN160016
- Product code
- PRA
- Regulation
- 866.3316
- Classification name
- variola virus nucleic acid-based detection assay
- Decision
- granted (DENG)
- Decision date
- 2017-02-06
- Date received
- 2016-04-14
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PRA
- Device name
- Variola Virus Nucleic Acid-Based Detection Assay
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3316
- Implant
- N
- Life sustain/support
- N