Product code LSE
- Device name
- Epstein-Barr Virus, Other
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.3235
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233606 | ADVIA Centaur EBV-VCA IgM | Biokit, S.A. | 2024-08-07 |
| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | DiaSorin, Inc. | 2017-01-05 |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | DiaSorin, Inc. | 2017-01-04 |
| K091260 | SERAQUEST EBV EA-D IGG TEST | Quest Intl., Inc. | 2009-06-08 |
| K073382 | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | Focus Diagnostics, Inc. | 2008-07-28 |
| K062211 | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories, Inc. | 2006-12-08 |
| K062213 | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | Bio-Rad Laboratories, Inc. | 2006-12-08 |
| K060204 | LIAISON EA IGG | DiaSorin, Inc. | 2006-10-18 |
| K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | Quest Intl., Inc. | 2004-01-16 |
| K030863 | EBV VCA-P18 IGG ELISA | Panbio Limited | 2003-06-27 |
| K021793 | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-09-27 |
| K010301 | IMMUNOWELL EA (D) IGG TEST | Genbio | 2001-06-11 |
| K992587 | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | Stellar Bio Systems, Inc. | 1999-12-22 |
| K991975 | SERAQUEST EB NA IGG | Quest Intl., Inc. | 1999-11-02 |
| K990410 | SERAQUEST EB VCA IGG | Quest Intl., Inc. | 1999-10-28 |
| K992191 | ETI-EA-G ASSAY | DiaSorin, Inc. | 1999-07-12 |
| K983841 | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | Biotest Diagnostics Corp. | 1999-06-09 |
| K983842 | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | Biotest Diagnostics Corp. | 1999-06-09 |
| K983839 | BIOTEST ANTI-EBV RECOMBINANT | Biotest Diagnostics Corp. | 1999-06-09 |
| K991660 | COPALIS MULTIPLEX EBV ANTIBODY ASSAY | DiaSorin, Inc. | 1999-06-04 |
| K981812 | EBV-VCA IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-03-04 |
| K983801 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO | Zeus Scientific, Inc. | 1998-12-10 |
| K983804 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | 1998-12-08 |
| K982352 | VCA IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-25 |
| K982348 | EBNA-1 IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-25 |
| K982350 | EA-D IGM ELISA TEST SYSTEM | Columbia Bioscience, Inc. | 1998-11-25 |
| K974226 | IMMUNODOT MONO-G TEST | Genbio | 1998-09-22 |
| K974244 | IMMUNODOT MONO-M TEST | Genbio | 1998-09-22 |
| K981120 | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA | Zeus Scientific, Inc. | 1998-08-21 |
| K973940 | IMMUNOWELL EBV VCA IGG TEST | Genbio | 1998-08-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048474027945 | Epstein Barr Virus VCA IgM ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 04048474027969 | EBV-EA IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239027948 | Epstein Barr Virus VCA IgM ELISA | DRG International Inc | 2023-08-24 |
| 00840239027962 | EBV-EA IgG ELISA | DRG International Inc | 2023-08-24 |
| 00847865011167 | Bio-Rad Laboratories | Bio-RAD Laboratories, Inc. | 2023-01-22 |
| 03610522051243 | Bio-Rad | Bio-RAD Laboratories, Inc. | 2023-01-21 |
| 00847865010788 | Bio-Rad Laboratories | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 00847865010795 | Bio-Rad Laboratories | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| B3507206000 | Gold Standard Diagnostics Is-EBV-VCA IgG Test Kit | Gold Standard Diagnostics Corporation | 2022-12-07 |
| B3507206100 | Gold Standard Diagnostics Is-EBV-VCA IgM Test Kit | Gold Standard Diagnostics Corporation | 2022-12-07 |
| B3507206500 | Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit | Gold Standard Diagnostics Corporation | 2022-12-07 |
| 00840733103247 | MERIFLUOR EBV-EA IgG IFA | MERIDIAN BIOSCIENCE, INC. | 2020-12-09 |
| B3507206300 | Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-07-27 |
| 05391516746564 | Bio-Rad Platelia | CLARK LABORATORIES, INC. | 2019-11-14 |
| 05391516746540 | Bio-Rad Platelia | CLARK LABORATORIES, INC. | 2019-11-07 |
| 05391516743365 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-11-05 |
| 05391516746953 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-11-05 |
| 05391516743334 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 05391516743556 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 05391516746946 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 05391516747080 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 05391516747196 | Platelia | CLARK LABORATORIES, INC. | 2019-08-06 |
| 00847865000161 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002127 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002226 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012607 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012614 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00850487007166 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00850487007180 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00850487007197 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |