Sars-cov-2 Serology Test
Microbiology · 21 CFR 866.3983
A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
15 firms currently registered for this product code
Ortho-clinical Diagnostics
Pencoed Bridgend, GB
Ortho Clinical Diagnostics
Singapore South West, SG
Ortho Clinical Diagnostics, K.k.
Harumi, Chuo-ku Tokyo, JP
Ortho-clinical Diagnostics, Inc.
RARITAN, NJ, US
Ortho-clinical Diagnostics European Support Center
Illkirch, CEDEX Bas-Rhin, FR
Ortho-clinical Diagnostics, Inc.
Rochester, NY, US
Epitope Diagnostics, Inc.
SAN DIEGO, CA, US
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
510(k) clearances
5 clearances for this product code
- Roche DiagnosticsApr 13, 2026
K252280 · Elecsys Anti-SARS-CoV-2 S
- Roche DiagnosticsDec 17, 2025
K253839 · Elecsys Anti-SARS-CoV-2
- Roche DiagnosticsJun 10, 2025
K250768 · Elecsys Anti-SARS-CoV-2
- Ortho-Clinical Diagnostics, Inc.May 5, 2023
DEN210040 · VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
- Ortho-Clinical Diagnostics, Inc.May 5, 2023
DEN210038 · VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator