Clearance Summary
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators received FDA 510(k) clearance under submission number DEN210040, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-05-05.
- Submission: DEN210040
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Direct
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3983
- Decision date: 2023-05-05
Classification & Regulation
This clearance is catalogued under FDA product code QVP and 21 CFR 866.3983, within the Microbiology review panel as a Class II device.