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FDA 510(k)

Elecsys Anti-SARS-CoV-2

K-Number: K250768 · 2025-06-10

ApplicantRoche Diagnostics
Decision Date2025-06-10
Product CodeQVP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys Anti-SARS-CoV-2 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2025-06-10 under 510(k) number K250768. 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?

Elecsys Anti-SARS-CoV-2 is a medical device that received FDA 510(k) clearance on 2025-06-10. The listed applicant is Roche Diagnostics. The 510(k) number is K250768.

When did Elecsys Anti-SARS-CoV-2 receive FDA 510(k) clearance?

Elecsys Anti-SARS-CoV-2 received FDA 510(k) clearance on 2025-06-10, under 510(k) number K250768.

Who is the listed applicant for Elecsys Anti-SARS-CoV-2?

The FDA 510(k) record lists Roche Diagnostics as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Roche Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QVP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252280Elecsys Anti-SARS-CoV-2 SRoche DiagnosticsK253839Elecsys Anti-SARS-CoV-2Roche Diagnostics

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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