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) → LJN — Antibody Igm, If, Epstein-Barr Virus # LJN · Antibody Igm, If, Epstein-Barr Virus _Microbiology · 21 CFR 866.3235 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN ## Overview - **Product Code:** LJN - **Device Name:** Antibody Igm, If, Epstein-Barr Virus - **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 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K123021](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K123021.md) | BIOPLEX 2200 EBV IGM KIT | Bio-Rad Laboratories | Nov 2, 2012 | SESE | | [K073381](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K073381.md) | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | Focus Diagnostics, Inc. | Aug 4, 2008 | SESE | | [K042092](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K042092.md) | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | Zeus Scientific, Inc. | Apr 12, 2005 | SESE | | [K033780](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K033780.md) | MODIFICATION TO SERAQUEST VCA IGM | Quest Intl., Inc. | Jan 15, 2004 | SESE | | [K990977](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K990977.md) | SERAQUEST EB VAC IGM | Quest Intl., Inc. | Oct 6, 1999 | SESE | | [K991459](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K991459.md) | COPALIS EBV-M ANTIBODY ASSAY | DiaSorin, Inc. | May 14, 1999 | SESE | | [K973939](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K973939.md) | IMMUNOWELL VCA IGM TEST | Genbio | Aug 10, 1998 | SESE | | [K931520](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K931520.md) | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY | Mrl Diagnostics | Apr 26, 1994 | SESE | | [K930020](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K930020.md) | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | Jul 16, 1993 | SESE | | [K922331](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K922331.md) | BARTELS EPSTEIN-BARR VIRUS IGM EIA | Baxter Diagnostics, Inc. | Sep 2, 1992 | SESE | | [K915348](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K915348.md) | EBV-VCA IGM ELISA | Pharmacia Diagnostics, Inc. | Feb 14, 1992 | SESE | | [K911362](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K911362.md) | AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST | Amico Laboratories, Inc. | Oct 7, 1991 | SESE | | [K910042](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K910042.md) | EBV IGM ELISA TEST | Gull Laboratories, Inc. | Feb 21, 1991 | SESE | | [K901840](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K901840.md) | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | Sep 12, 1990 | SESE | | [K896594](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K896594.md) | EBV VCA ANTIBODY (IGM) | Hillcrest Biologicals | Jan 16, 1990 | SESE | | [K893240](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K893240.md) | BION EBV-M (VCA) TEST SYSTEM | Bion Ent., Ltd. | Jul 14, 1989 | SESE | | [K890639](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K890639.md) | RESUBMITTED EBV/IGM-CHECK TEST KIT | Diagnostic Technology, Inc. | Jun 20, 1989 | SESE | | [K880886](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K880886.md) | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE | | [K880884](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K880884.md) | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE | | [K875204](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN/K875204.md) | DU PONT VCA-IGM ANTIBODY ELISA KIT | E.I. Dupont DE Nemours & Co., Inc. | Jul 8, 1988 | SESE | ## Top Applicants - Granbio, Inc. — 2 clearances - Immuno Concepts, Inc. — 2 clearances - Ortho Diagnostic Systems, Inc. — 2 clearances - Quest Intl., Inc. — 2 clearances - Zeus Scientific, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LJN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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