Elecsys Anti-SARS-CoV-2 S— 510(k) K252280
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K252280 for Elecsys Anti-SARS-CoV-2 S, Substantially Equivalent on 2026-04-13. Applicant: Roche Diagnostics. Device class: 2.
Summary
Roche Diagnostics' Elecsys Anti-SARS-CoV-2 S is filed under product code QVP (Sars-Cov-2 Serology Test).
Class II, 21 CFR 866.3983. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Roche Diagnostics filed from Indianapolis, Indiana. The decision came 265 calendar days after FDA received it (July 22, 2025 to April 13, 2026).
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Product code QVP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3983
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from Roche Diagnostics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.