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FDA 510(k)

Elecsys Anti-SARS-CoV-2 S

K-Number: K252280 · 2026-04-13

ApplicantRoche Diagnostics
Decision Date2026-04-13
Product CodeQVP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-SARS-CoV-2 S is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2026-04-13 under approval number K252280. The device is classified under product code QVP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys Anti-SARS-CoV-2 S?

Elecsys Anti-SARS-CoV-2 S is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by Roche Diagnostics. The 510(k) number is K252280.

When was Elecsys Anti-SARS-CoV-2 S approved by the FDA?

Elecsys Anti-SARS-CoV-2 S received FDA 510(k) clearance on 2026-04-13, under approval number K252280.

What company makes Elecsys Anti-SARS-CoV-2 S?

Elecsys Anti-SARS-CoV-2 S is manufactured by Roche Diagnostics.

What is the FDA product code for Elecsys Anti-SARS-CoV-2 S?

The FDA product code for Elecsys Anti-SARS-CoV-2 S is QVP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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