GNP · Antiserum, Cf, Epstein-Barr Virus
Microbiology · 21 CFR 866.3235 · Class 1
Overview
| Product Code | GNP |
|---|---|
| Device Name | Antiserum, Cf, Epstein-Barr Virus |
| Regulation | 21 CFR 866.3235 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 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 | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | Pan Bio Pty. , Ltd. | Jun 13, 2002 | SESE |
| K020707 | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | Jun 13, 2002 | SESE |
| K020706 | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | Pan Bio Pty. , Ltd. | Jun 13, 2002 | SESE |
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | Diamedix Corp. | Feb 16, 1999 | SESE |
| K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | Diamedix Corp. | Feb 16, 1999 | SESE |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | Sep 12, 1990 | SESE |
| K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | Electro-Nucleonics, Inc. | Apr 28, 1989 | SESE |
| K884591 | EBV-VCA ANTIBODY (IGG) | Hillcrest Biologicals | Jan 24, 1989 | SESE |
| K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE |
| K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Diagnostic Technology, Inc. | Jun 25, 1987 | SESE |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Granbio, Inc. | Feb 2, 1987 | SESE |
| K861121 | THE GOLDEN QUAD TEST (EBV) | Microbiological Research Corp. | Feb 2, 1987 | SESE |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Diagnostic Technology, Inc. | Nov 28, 1986 | SESE |
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Immuno-Diagnostic Products, Inc. | Apr 24, 1986 | SESE |
| K853484 | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT | Biotech Research Laboratories, Inc. | Feb 5, 1986 | SESE |
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | Amico Lab, Inc. | Dec 12, 1985 | SESE |
| K842530 | AMIZYME-EBV TEST KIT | Amico Lab, Inc. | Dec 6, 1985 | SESE |
| K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | Electro-Nucleonics Laboratories, Inc. | May 5, 1981 | SESE |
| K771062 | 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
