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

FDA 510(k)

Elecsys EBV EBNA IgG

K-Number: K260221 · 2026-10-02

ApplicantRoche Diagnostics
Decision Date2026-10-02
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys EBV EBNA IgG is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K260221. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elecsys EBV EBNA IgG?

Elecsys EBV EBNA IgG is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is Roche Diagnostics. The 510(k) number is K260221.

When did Elecsys EBV EBNA IgG receive FDA 510(k) clearance?

Elecsys EBV EBNA IgG received FDA 510(k) clearance on 2026-10-02, under 510(k) number K260221.

Who is the listed applicant for Elecsys EBV EBNA IgG?

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 EBV EBNA IgG?

The FDA product code for Elecsys EBV EBNA IgG is LSE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K260233Elecsys EBV IgMK260232Elecsys EBV VCA IgGK261686Elecsys Phospho-Tau (217P) PlasmaK252323cobas pulse blood glucose monitoring systemK252280Elecsys Anti-SARS-CoV-2 SK260049Elecsys Anti-HBc IgM

View all 167 devices →

Related Devices (Code: LSE)

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.

K260232Elecsys EBV VCA IgGRoche DiagnosticsK233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.

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.

↑