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De Novo DEN220039
- Device
- Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
- Contact
- xiaoxi wang
- De Novo number
- DEN220039
- Product code
- QVF
- Regulation
- 866.3982
- Classification name
- simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings
- Decision
- granted (DENG)
- Decision date
- 2023-03-08
- Date received
- 2022-06-16
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- QVF
- Device name
- Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3982
- Implant
- N
- Life sustain/support
- N