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) → LLM — Test, Antigen, Nuclear, Epstein-Barr Virus # LLM · Test, Antigen, Nuclear, Epstein-Barr Virus _Microbiology · 21 CFR 866.3235 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM ## Overview - **Product Code:** LLM - **Device Name:** Test, Antigen, Nuclear, 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 27) Showing 20 most recent of 27 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K233605](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K233605.md) | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | Aug 7, 2024 | SESE | | [K040120](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K040120.md) | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS | DiaSorin, Inc. | Apr 29, 2005 | SESE | | [K984133](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K984133.md) | THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | Zeus Scientific, Inc. | Jan 11, 1999 | SESE | | [K973941](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K973941.md) | IMMUNOWELL EBNA IGG TEST | Genbio | Aug 10, 1998 | SESE | | [K980598](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K980598.md) | EBNA-1 IGM ELISA TEST SYSTEM | Clark Laboratories, Inc. | May 1, 1998 | SESE | | [K951549](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K951549.md) | EBNA IGG EIA TEST SYSTEM | Immunoprobe, Inc. | Apr 29, 1996 | SESE | | [K951822](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K951822.md) | EBNA ENZYME IMMUNOASSAY KIT | Granbio, Inc. | Feb 15, 1996 | SESE | | [K935730](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K935730.md) | EBNA IGG ELISA TEST | Gull Laboratories, Inc. | Sep 19, 1995 | SESE | | [K946353](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K946353.md) | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY | Mrl Diagnostics | Jul 21, 1995 | SESE | | [K946158](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K946158.md) | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT | Incstar Corp. | Jun 9, 1995 | SESE | | [K932742](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K932742.md) | EBNA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | May 5, 1995 | SESE | | [K925690](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K925690.md) | MERIDIAN EBNA TEST KIT | Fuller Laboratories, Inc. | Oct 12, 1993 | SESE | | [K930002](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K930002.md) | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | Jul 16, 1993 | SESE | | [K911473](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K911473.md) | EBNA STAT TEST KIT | Whittaker Bioproducts, Inc. | Sep 25, 1991 | SESE | | [K911569](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K911569.md) | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | Jun 10, 1991 | SESE | | [K895708](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K895708.md) | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | Immuno Concepts, Inc. | Dec 11, 1989 | SESE | | [K895707](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K895707.md) | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) | Immuno Concepts, Inc. | Dec 8, 1989 | SESE | | [K894626](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K894626.md) | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | Bion Ent., Ltd. | Oct 16, 1989 | SESE | | [K891542](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K891542.md) | EBNA-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | Jun 20, 1989 | SESE | | [K883601](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM/K883601.md) | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | Clinical Sciences, Inc. | May 11, 1989 | SESE | ## Top Applicants - Zeus Scientific, Inc. — 3 clearances - Ortho Diagnostic Systems, Inc. — 2 clearances - Immuno Concepts, Inc. — 2 clearances - Gull Laboratories, Inc. — 2 clearances - Granbio, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LLM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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