Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3235](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3235) → LSE — Epstein-Barr Virus, Other # LSE · Epstein-Barr Virus, Other _Microbiology · 21 CFR 866.3235 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE ## Overview - **Product Code:** LSE - **Device Name:** Epstein-Barr Virus, Other - **Regulation:** [21 CFR 866.3235](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3235) - **Device Class:** 1 - **Review Panel:** [Microbiology](/submissions/MI) - **3rd-party reviewable:** yes ## Identification Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer). ## Classification Rationale Class I (general controls). ## Recent Cleared Devices (20 of 56) Showing 20 most recent of 56 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233606](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K233606.md) | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | Aug 7, 2024 | SESE | | [K162961](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K162961.md) | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | DiaSorin, Inc. | Jan 5, 2017 | SESE | | [K162959](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K162959.md) | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | DiaSorin, Inc. | Jan 4, 2017 | SESE | | [K091260](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K091260.md) | SERAQUEST EBV EA-D IGG TEST | Quest Intl., Inc. | Jun 8, 2009 | SESE | | [K073382](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K073382.md) | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Focus Diagnostics, Inc. | Jul 28, 2008 | SESE | | [K062213](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K062213.md) | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories, Inc. | Dec 8, 2006 | SESE | | [K062211](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K062211.md) | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories, Inc. | Dec 8, 2006 | SESE | | [K060204](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K060204.md) | LIAISON EA IGG | DiaSorin, Inc. | Oct 18, 2006 | SESE | | [K033915](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K033915.md) | MODIFICATION TO SERAQUEST EB VCA IGG | Quest Intl., Inc. | Jan 16, 2004 | SESE | | [K030863](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K030863.md) | EBV VCA-P18 IGG ELISA | Panbio Limited | Jun 27, 2003 | SESE | | [K021793](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K021793.md) | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | Sep 27, 2002 | SESE | | [K010301](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K010301.md) | IMMUNOWELL EA (D) IGG TEST | Genbio | Jun 11, 2001 | SESE | | [K992587](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K992587.md) | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | Stellar Bio Systems, Inc. | Dec 22, 1999 | SESE | | [K991975](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K991975.md) | SERAQUEST EB NA IGG | Quest Intl., Inc. | Nov 2, 1999 | SESE | | [K990410](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K990410.md) | SERAQUEST EB VCA IGG | Quest Intl., Inc. | Oct 28, 1999 | SESE | | [K992191](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K992191.md) | ETI-EA-G ASSAY | DiaSorin, Inc. | Jul 12, 1999 | SESE | | [K983842](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K983842.md) | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | Biotest Diagnostics Corp. | Jun 9, 1999 | SESE | | [K983841](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K983841.md) | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | Biotest Diagnostics Corp. | Jun 9, 1999 | SESE | | [K983839](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K983839.md) | BIOTEST ANTI-EBV RECOMBINANT | Biotest Diagnostics Corp. | Jun 9, 1999 | SESE | | [K991660](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE/K991660.md) | COPALIS MULTIPLEX EBV ANTIBODY ASSAY | DiaSorin, Inc. | Jun 4, 1999 | SESE | ## Top Applicants - DiaSorin, Inc. — 5 clearances - Zeus Scientific, Inc. — 5 clearances - Genbio — 4 clearances - Quest Intl., Inc. — 4 clearances - Whittaker Bioproducts, Inc. — 4 clearances --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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