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VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator

Ortho-Clinical Diagnostics, Inc. · Class II · Cleared May 5, 2023

K-numberDEN210038
Device nameVITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
ApplicantOrtho-Clinical Diagnostics, Inc.
Product codeQVP
Device classClass II
Decision dateMay 5, 2023
DecisionNot Substantially Equivalent
Regulation866.3983
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View the full FDA submission: accessdata.fda.gov

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