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) → GNP — Antiserum, Cf, Epstein-Barr Virus # GNP · Antiserum, Cf, Epstein-Barr Virus _Microbiology · 21 CFR 866.3235 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP ## Overview - **Product Code:** GNP - **Device Name:** Antiserum, Cf, 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 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K020717](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K020717.md) | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | Pan Bio Pty. , Ltd. | Jun 13, 2002 | SESE | | [K020707](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K020707.md) | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | Jun 13, 2002 | SESE | | [K020706](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K020706.md) | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | Pan Bio Pty. , Ltd. | Jun 13, 2002 | SESE | | [K981831](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K981831.md) | IS EBV-EA-D IGG ELISA TEST SYSTEM | Diamedix Corp. | Feb 16, 1999 | SESE | | [K981829](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K981829.md) | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | Diamedix Corp. | Feb 16, 1999 | SESE | | [K901156](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K901156.md) | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | Sep 12, 1990 | SESE | | [K883670](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K883670.md) | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | Electro-Nucleonics, Inc. | Apr 28, 1989 | SESE | | [K884591](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K884591.md) | EBV-VCA ANTIBODY (IGG) | Hillcrest Biologicals | Jan 24, 1989 | SESE | | [K880885](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K880885.md) | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE | | [K880883](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K880883.md) | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE | | [K871373](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K871373.md) | EBV-CHECK(TM) TEST KIT (IGG) | Diagnostic Technology, Inc. | Jun 25, 1987 | SESE | | [K864347](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K864347.md) | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Granbio, Inc. | Feb 2, 1987 | SESE | | [K861121](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K861121.md) | THE GOLDEN QUAD TEST (EBV) | Microbiological Research Corp. | Feb 2, 1987 | SESE | | [K863408](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K863408.md) | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Diagnostic Technology, Inc. | Nov 28, 1986 | SESE | | [K854207](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K854207.md) | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Immuno-Diagnostic Products, Inc. | Apr 24, 1986 | SESE | | [K853484](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K853484.md) | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT | Biotech Research Laboratories, Inc. | Feb 5, 1986 | SESE | | [K842662](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K842662.md) | ANTI-EPSTEIN-BARR VIRUS KIT | Amico Lab, Inc. | Dec 12, 1985 | SESE | | [K842530](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K842530.md) | AMIZYME-EBV TEST KIT | Amico Lab, Inc. | Dec 6, 1985 | SESE | | [K810860](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K810860.md) | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | Electro-Nucleonics Laboratories, Inc. | May 5, 1981 | SESE | | [K771062](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP/K771062.md) | EBV TEST | Gull Laboratories, Inc. | Jul 14, 1977 | SESE | ## Top Applicants - Pan Bio Pty. , Ltd. — 3 clearances - Amico Lab, Inc. — 2 clearances - Diagnostic Technology, Inc. — 2 clearances - Diamedix Corp. — 2 clearances - Granbio, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GNP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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