Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2025-06-10 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K250768.

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

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

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

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

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 Devices by Roche Diagnostics

DEN150057Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker K160910Elecsys Syphilis K153607ROMA Calculation Tool Using Elecsys Assays K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 K152227Elecsys Cortisol II, Cortisol II CalSet

View all 70 devices →

Related Devices (Code: QVP)

DEN210040VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total CalibratorsOrtho-Clinical Diagnostics, Inc. DEN210038VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG CalibratorOrtho-Clinical Diagnostics, Inc. K253839Elecsys Anti-SARS-CoV-2Roche Diagnostics K252280Elecsys Anti-SARS-CoV-2 SRoche 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.

↑