Product code LJN
- Device name
- Antibody Igm, If, Epstein-Barr Virus
- 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 |
|---|---|---|---|
| K123021 | BIOPLEX 2200 EBV IGM KIT | Bio-Rad Laboratories | 2012-11-02 |
| K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | Focus Diagnostics, Inc. | 2008-08-04 |
| K042092 | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | Zeus Scientific, Inc. | 2005-04-12 |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | Quest Intl., Inc. | 2004-01-15 |
| K990977 | SERAQUEST EB VAC IGM | Quest Intl., Inc. | 1999-10-06 |
| K991459 | COPALIS EBV-M ANTIBODY ASSAY | DiaSorin, Inc. | 1999-05-14 |
| K973939 | IMMUNOWELL VCA IGM TEST | Genbio | 1998-08-10 |
| K931520 | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY | Mrl Diagnostics | 1994-04-26 |
| K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 |
| K922331 | BARTELS EPSTEIN-BARR VIRUS IGM EIA | Baxter Diagnostics, Inc. | 1992-09-02 |
| K915348 | EBV-VCA IGM ELISA | Pharmacia Diagnostics, Inc. | 1992-02-14 |
| K911362 | AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST | Amico Laboratories, Inc. | 1991-10-07 |
| K910042 | EBV IGM ELISA TEST | Gull Laboratories, Inc. | 1991-02-21 |
| K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | 1990-09-12 |
| K896594 | EBV VCA ANTIBODY (IGM) | Hillcrest Biologicals | 1990-01-16 |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-07-14 |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 |
| K880884 | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | 1988-08-30 |
| K880886 | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | 1988-08-30 |
| K875204 | DU PONT VCA-IGM ANTIBODY ELISA KIT | E.I. Dupont DE Nemours & Co., Inc. | 1988-07-08 |
| K872541 | ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. | Ortho Diagnostic Systems, Inc. | 1988-05-13 |
| K864604 | EBV VCA IGM ANTIBODY ASSAY KIT | Granbio, Inc. | 1987-02-02 |
| K833014 | EBV-VCA-IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | 1983-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00847865010801 | Bio-Rad Laboratories | Bio-RAD Laboratories, Inc. | 2023-01-04 |
| 00847865000291 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| B110EB50120 | Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110EBG50200 | EBV IgG Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110EBM1200 | EBV-VCA IgM Test System, 120 Tests | Bion Enterprises, Ltd. | 2016-09-12 |
| B110EBM50300 | EBV IgM Control | Bion Enterprises, Ltd. | 2016-09-12 |
| B110EBN50100 | EBV Negative Control | Bion Enterprises, Ltd. | 2016-09-12 |
| 00847865001236 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865002455 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865011341 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865011358 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00850487007173 | ReQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00850487007418 | SeraQuest | QUEST INTERNATIONAL, INC. | 2016-08-31 |
| 00816057020652 | ASI EB VCA IgM EIA Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |