Elecsys Anti-SARS-CoV-2 S
Device Facts
| Record ID | K252280 |
|---|---|
| Device Name | Elecsys Anti-SARS-CoV-2 S |
| Applicant | Roche Diagnostics |
| Product Code | QVP · Microbiology |
| Decision Date | Apr 13, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3983 |
| Device Class | Class 2 |
Regulatory Classification
Identification
The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test is a qualitative chemiluminescent immunoassay intended for the detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (K2-EDTA and K3-EDTA). It is performed on the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
