Skip to contentDe Novo DEN220028
- Device
- Cue COVID-19 Molecular Test
- Contact
- roderick castillo
- De Novo number
- DEN220028
- Product code
- QWB
- Regulation
- 866.3984
- Classification name
- over-the-counter molecular test to detect sars-cov-2 from clinical specimens
- Decision
- granted (DENG)
- Decision date
- 2023-06-06
- Date received
- 2022-05-02
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QWB
- Device name
- Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3984
- Implant
- N
- Life sustain/support
- N