De Novo DEN210040
- Device
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
- Contact
- marlene hanna
- De Novo number
- DEN210040
- Product code
- QVP
- Regulation
- 866.3983
- Classification name
- sars-cov-2 serology test
- Decision
- granted (DENG)
- Decision date
- 2023-05-05
- Date received
- 2021-09-21
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QVP
- Device name
- Sars-Cov-2 Serology Test
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3983
- Implant
- N
- Life sustain/support
- N