LSE · Epstein-Barr Virus, Other
Microbiology · 21 CFR 866.3235 · Class 1
Overview
| Product Code | LSE |
|---|---|
| Device Name | Epstein-Barr Virus, Other |
| 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 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | Aug 7, 2024 | SESE |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | DiaSorin, Inc. | Jan 5, 2017 | SESE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | DiaSorin, Inc. | Jan 4, 2017 | SESE |
| K091260 | SERAQUEST EBV EA-D IGG TEST | Quest Intl., Inc. | Jun 8, 2009 | SESE |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Focus Diagnostics, Inc. | Jul 28, 2008 | SESE |
| K062213 | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories, Inc. | Dec 8, 2006 | SESE |
| K062211 | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories, Inc. | Dec 8, 2006 | SESE |
| K060204 | LIAISON EA IGG | DiaSorin, Inc. | Oct 18, 2006 | SESE |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | Quest Intl., Inc. | Jan 16, 2004 | SESE |
| K030863 | EBV VCA-P18 IGG ELISA | Panbio Limited | Jun 27, 2003 | SESE |
| K021793 | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | Sep 27, 2002 | SESE |
| K010301 | IMMUNOWELL EA (D) IGG TEST | Genbio | Jun 11, 2001 | SESE |
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | Stellar Bio Systems, Inc. | Dec 22, 1999 | SESE |
| K991975 | SERAQUEST EB NA IGG | Quest Intl., Inc. | Nov 2, 1999 | SESE |
| K990410 | SERAQUEST EB VCA IGG | Quest Intl., Inc. | Oct 28, 1999 | SESE |
| K992191 | ETI-EA-G ASSAY | DiaSorin, Inc. | Jul 12, 1999 | SESE |
| K983842 | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | Biotest Diagnostics Corp. | Jun 9, 1999 | SESE |
| K983841 | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | Biotest Diagnostics Corp. | Jun 9, 1999 | SESE |
| K983839 | BIOTEST ANTI-EBV RECOMBINANT | Biotest Diagnostics Corp. | Jun 9, 1999 | SESE |
| K991660 | COPALIS MULTIPLEX EBV ANTIBODY ASSAY | DiaSorin, Inc. | Jun 4, 1999 | SESE |
Top Applicants
- DiaSorin, Inc. — 5 clearances
- Zeus Scientific, Inc. — 5 clearances
- Genbio — 4 clearances
- Quest Intl., Inc. — 4 clearances
- Whittaker Bioproducts, Inc. — 4 clearances
