LJN · Antibody Igm, If, Epstein-Barr Virus
Microbiology · 21 CFR 866.3235 · Class 1
Overview
| Product Code | LJN |
|---|---|
| Device Name | Antibody Igm, If, 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 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K123021 | BIOPLEX 2200 EBV IGM KIT | Bio-Rad Laboratories | Nov 2, 2012 | SESE |
| K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | Focus Diagnostics, Inc. | Aug 4, 2008 | SESE |
| K042092 | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | Zeus Scientific, Inc. | Apr 12, 2005 | SESE |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | Quest Intl., Inc. | Jan 15, 2004 | SESE |
| K990977 | SERAQUEST EB VAC IGM | Quest Intl., Inc. | Oct 6, 1999 | SESE |
| K991459 | COPALIS EBV-M ANTIBODY ASSAY | DiaSorin, Inc. | May 14, 1999 | SESE |
| K973939 | IMMUNOWELL VCA IGM TEST | Genbio | Aug 10, 1998 | SESE |
| K931520 | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY | Mrl Diagnostics | Apr 26, 1994 | SESE |
| K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | Jul 16, 1993 | SESE |
| K922331 | BARTELS EPSTEIN-BARR VIRUS IGM EIA | Baxter Diagnostics, Inc. | Sep 2, 1992 | SESE |
| K915348 | EBV-VCA IGM ELISA | Pharmacia Diagnostics, Inc. | Feb 14, 1992 | SESE |
| K911362 | AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST | Amico Laboratories, Inc. | Oct 7, 1991 | SESE |
| K910042 | EBV IGM ELISA TEST | Gull Laboratories, Inc. | Feb 21, 1991 | SESE |
| K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | Sep 12, 1990 | SESE |
| K896594 | EBV VCA ANTIBODY (IGM) | Hillcrest Biologicals | Jan 16, 1990 | SESE |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | Bion Ent., Ltd. | Jul 14, 1989 | SESE |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | Diagnostic Technology, Inc. | Jun 20, 1989 | SESE |
| K880886 | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE |
| K880884 | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | Aug 30, 1988 | SESE |
| K875204 | 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
