Class Class II
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (DEN210040)
Description
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators by Ortho-Clinical Diagnostics, Inc. — FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberDEN210040
Clearance Date2023-05-05
Clearance TypeDirect
Product CodeQVP
Regulation Number866.3983