FDA 510(k) Applications for Medical Device Product Code: QVP ()

FDA 510(k) Applications for Medical Device Product Code "QVP"

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN210038	Ortho-Clinical Diagnostics, Inc.	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator	05/05/2023
DEN210040	Ortho-Clinical Diagnostics, Inc.	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators	05/05/2023
K250768	Roche Diagnostics	Elecsys Anti-SARS-CoV-2	06/10/2025