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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)

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Device Classification Name sars-cov-2 serology test
De Novo Number DEN210040
Device Name VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
Ortho-Clinical Diagnostics, Inc.
100 indigo creek drive
rochester,  NY  14626
Contact marlene hanna
Regulation Number866.3983
Classification Product Code
Date Received09/21/2021
Decision Date 05/05/2023
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct