Epstein-Barr Virus, Other
FDA product code LSE · Class I (low risk) · 21 CFR 866.3235 · Microbiology
56510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Zeus Scientific, Inc. 5
- DiaSorin, Inc. 5
- Whittaker Bioproducts, Inc. 4
- Quest Intl., Inc. 4
- Genbio 4
- Gull Laboratories, Inc. 3
- Biotest Diagnostics Corp. 3
- Columbia Bioscience, Inc. 3
- Incstar Corp. 3
- Clark Laboratories, Inc. 3
- Granbio, Inc. 2
- Bio-Rad Laboratories, Inc. 2
- Immuno Concepts, Inc. 2
- Clinical Sciences, Inc. 2
- Ortho Diagnostic Systems, Inc. 1
- Fuller Laboratories, Inc. 1
- Baxter Diagnostics, Inc. 1
- Diamedix Corp. 1
- Diagnostic Technology, Inc. 1
- Organon Teknika Treyburn 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgMLSE · Traditional | Biokit, S.A. | 08/07/2024SE |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…LSE · Special | DiaSorin, Inc. | 01/05/2017SE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE · Special | DiaSorin, Inc. | 01/04/2017SE |
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | Quest Intl., Inc. | 06/08/2009SE |
| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500GLSE · Traditional | Focus Diagnostics, Inc. | 07/28/2008SE |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K060204 | Liaison Ea IggLSE · Traditional | DiaSorin, Inc. | 10/18/2006SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | Quest Intl., Inc. | 01/16/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | Panbio Limited | 06/27/2003SE |
| K021793 | Ebv Ea-D Igg Elisa Kit, Model EBG-100LSE · Traditional | Pan Bio Pty. , Ltd. | 09/27/2002SE |
| K010301 | Immunowell Ea (D) Igg TestLSE · Traditional | Genbio | 06/11/2001SE |
| K992587 | Epstein-Barr Virus Early Antigen (Ebv-Ea) Igg Ifa Test SystemLSE · Traditional | Stellar Bio Systems, Inc. | 12/22/1999SE |
| K991975 | Seraquest Eb Na IggLSE · Traditional | Quest Intl., Inc. | 11/02/1999SE |
| K990410 | Seraquest Eb Vca IggLSE · Traditional | Quest Intl., Inc. | 10/28/1999SE |
| K992191 | Eti-Ea-G AssayLSE · Traditional | DiaSorin, Inc. | 07/12/1999SE |
| K983842 | Biotest Anti-Ebv Recombinant, Ea IgmLSE · Traditional | Biotest Diagnostics Corp. | 06/09/1999SE |
| K983841 | Biotest Anti-Ebv Recombinant, Ebna IggLSE · Traditional | Biotest Diagnostics Corp. | 06/09/1999SE |
| K983839 | Biotest Anti-Ebv RecombinantLSE · Traditional | Biotest Diagnostics Corp. | 06/09/1999SE |
| K991660 | Copalis Multiplex Ebv Antibody AssayLSE · Traditional | DiaSorin, Inc. | 06/04/1999SE |
| K981812 | Ebv-Vca Igg Elisa Test SystemLSE · Traditional | Diamedix Corp. | 03/04/1999SE |
| K983801 | The Aptus (Automated) Application of the Ebv-Vca Igm Elisa Test System. an Enzyme Linked…LSE · Traditional | Zeus Scientific, Inc. | 12/10/1998SE |
| K983804 | The Aptus (Automated) Application of the Ebv-Ea Igg Elisa Test System. an Enzyme Linked…LSE · Traditional | Zeus Scientific, Inc. | 12/08/1998SE |
| K982352 | Vca Igm Elisa Test SystemLSE · Traditional | Columbia Bioscience, Inc. | 11/25/1998SE |
| K982350 | Ea-D Igm Elisa Test SystemLSE · Traditional | Columbia Bioscience, Inc. | 11/25/1998SE |
| K982348 | EBNA-1 Igm Elisa Test SystemLSE · Traditional | Columbia Bioscience, Inc. | 11/25/1998SE |
| K974244 | Immunodot Mono-M TestLSE · Traditional | Genbio | 09/22/1998SE |
| K974226 | Immunodot Mono-G TestLSE · Traditional | Genbio | 09/22/1998SE |
| K981120 | Zeus Scientific Inc., Anti-Ebv Ea Igg ElisaLSE · Traditional | Zeus Scientific, Inc. | 08/21/1998SE |
| K973940 | Immunowell Ebv Vca Igg TestLSE · Traditional | Genbio | 08/10/1998SE |
| K980912 | Vca Igg Elisa Test SystemLSE · Traditional | Clark Laboratories, Inc. | 07/22/1998SE |
| K980596 | Vca Igm Elisa Test SystemLSE · Traditional | Clark Laboratories, Inc. | 07/22/1998SE |
| K973123 | Ea-D Igg Elisa Test SystemLSE · Traditional | Clark Laboratories, Inc. | 03/26/1998SE |
| K944449 | Ebv-Vca Igm Elisa Test StstemLSE · Traditional | Zeus Scientific, Inc. | 09/25/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | Gull Laboratories, Inc. | 09/15/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | Gull Laboratories, Inc. | 08/23/1995SE |
| K946159 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa KitLSE · Traditional | Incstar Corp. | 06/07/1995SE |
| K946157 | Incstar Epstein-Barr Viral Capsid Antigen (Vca) LGM Elisa KitLSE · Traditional | Incstar Corp. | 06/07/1995SE |
| K934774 | UnknownLSE · Traditional | Granbio, Inc. | 04/20/1994SE |
| K931443 | Ortho*Epstein-Barr Virus Ea(D+R)-Igg Antibody ElisLSE · Traditional | Ortho Diagnostic Systems, Inc. | 11/05/1993SE |
| K925688 | Meridian Ebv-Ea Test KitLSE · Traditional | Fuller Laboratories, Inc. | 10/12/1993SE |
| K921628 | Epstein-Barr Vir Early Anti Diff Igg Clin-ElisaLSE · Traditional | Incstar Corp. | 09/14/1992SE |
| K922332 | Bartels Epstein-Barr Virus Igg EiaLSE · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K912489 | Colorzyme Ebv Early Antigen Igg Antibody Test SysLSE · Traditional | Immuno Concepts, Inc. | 07/24/1991SE |
| K912488 | Fluorecent Ebv-Early Antigen Igg Antibody Test SysLSE · Traditional | Immuno Concepts, Inc. | 07/24/1991SE |
| K903612 | Ebv/Ea-Check TM Test KitLSE · Traditional | Diagnostic Technology, Inc. | 10/16/1990SE |
| K895652 | Ebv-Ea Ifa KitLSE · Traditional | Organon Teknika Treyburn | 12/18/1989SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | Whittaker Bioproducts, Inc. | 10/16/1989SE |
| K894235 | Eb Vca Stat M Test KitLSE · Traditional | Whittaker Bioproducts, Inc. | 08/30/1989SE |
| K883871 | Epstein-Barr Viral Capsid Antigen Igm #5590LSE · Traditional | Clinical Sciences, Inc. | 07/14/1989SE |
| K883870 | Epstein-Barr Viral Capsid Antigen Igg #4590LSE · Traditional | Clinical Sciences, Inc. | 07/14/1989SE |
| K891086 | Stat Test Kit for Eb-Vca Igg AntibodyLSE · Traditional | Whittaker Bioproducts, Inc. | 05/10/1989SE |
| K882447 | Epstein-Barr Virus Early Antigen (Ea) Antibody TesLSE · Traditional | Zeus Scientific, Inc. | 12/15/1988SE |
| K882023 | Fiax Test Kit for Eb-Vca-G AntibodyLSE · Traditional | Whittaker Bioproducts, Inc. | 08/03/1988SE |
| K881617 | Indirect Immunofluorescent Antibody AssayLSE · Traditional | Granbio, Inc. | 06/07/1988SE |
| K872617 | Ebv-Ea TestLSE · Traditional | Gull Laboratories, Inc. | 01/05/1988SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0735-2026 Class II | Epstein-Barr Virus (EBV VCA & EBNA IgG) TestDistribution without premarket approval/clearance. | Get Tested International AB | 11/03/2025Open, Classified |
| Z-1686-2016 Class II | Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure…A gel-like substance was found in kit component, sample diluent , that could potentially compromise product… | Diamedix Corporation | 10/20/2014Terminated |
| Z-2082-2011 | BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200. Product is labeled in part:…Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the… | Bio-Rad Laboratories | 03/11/2011Terminated |
| Z-0994-2010 | EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | Calbiotech Inc | 08/27/2008Terminated |
| Z-1158-2008 | BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 -…False negative results due to reagent packs exhibiting low signal. | Bio-Rad Laboratories | 11/13/2007Terminated |
| Z-1157-2008 | BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 -…False negative results due to reagent packs exhibiting low signal. | Bio-Rad Laboratories | 11/13/2007Terminated |