Clearance Summary
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set received FDA 510(k) clearance under submission number DEN220039, sponsored by Quidel Corporation. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-03-08.
- Submission: DEN220039
- Applicant / Sponsor: Quidel Corporation
- Clearance pathway: Post-NSE
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3982
- Decision date: 2023-03-08
Classification & Regulation
This clearance is catalogued under FDA product code QVF and 21 CFR 866.3982, within the Microbiology review panel as a Class II device.