LLM · Test, Antigen, Nuclear, Epstein-Barr Virus
Microbiology · 21 CFR 866.3235 · Class 1
Overview
| Product Code | LLM |
|---|---|
| Device Name | Test, Antigen, Nuclear, 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 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | Aug 7, 2024 | SESE |
| K040120 | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS | DiaSorin, Inc. | Apr 29, 2005 | SESE |
| K984133 | 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 | IMMUNOWELL EBNA IGG TEST | Genbio | Aug 10, 1998 | SESE |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | Clark Laboratories, Inc. | May 1, 1998 | SESE |
| K951549 | EBNA IGG EIA TEST SYSTEM | Immunoprobe, Inc. | Apr 29, 1996 | SESE |
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | Granbio, Inc. | Feb 15, 1996 | SESE |
| K935730 | EBNA IGG ELISA TEST | Gull Laboratories, Inc. | Sep 19, 1995 | SESE |
| K946353 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY | Mrl Diagnostics | Jul 21, 1995 | SESE |
| K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT | Incstar Corp. | Jun 9, 1995 | SESE |
| K932742 | EBNA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | May 5, 1995 | SESE |
| K925690 | MERIDIAN EBNA TEST KIT | Fuller Laboratories, Inc. | Oct 12, 1993 | SESE |
| K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | Jul 16, 1993 | SESE |
| K911473 | EBNA STAT TEST KIT | Whittaker Bioproducts, Inc. | Sep 25, 1991 | SESE |
| K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | Jun 10, 1991 | SESE |
| K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | Immuno Concepts, Inc. | Dec 11, 1989 | SESE |
| K895707 | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) | Immuno Concepts, Inc. | Dec 8, 1989 | SESE |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | Bion Ent., Ltd. | Oct 16, 1989 | SESE |
| K891542 | EBNA-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | Jun 20, 1989 | SESE |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | Clinical Sciences, Inc. | May 11, 1989 | SESE |
Top Applicants
- Zeus Scientific, Inc. — 3 clearances
- Clinical Sciences, Inc. — 2 clearances
- Granbio, Inc. — 2 clearances
- Gull Laboratories, Inc. — 2 clearances
- Immuno Concepts, Inc. — 2 clearances
