Product code LLM
- Device name
- Test, Antigen, Nuclear, 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 |
|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgG | Biokit, S.A. | 2024-08-07 |
| K040120 | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS | DiaSorin, Inc. | 2005-04-29 |
| K984133 | THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | Zeus Scientific, Inc. | 1999-01-11 |
| K973941 | IMMUNOWELL EBNA IGG TEST | Genbio | 1998-08-10 |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | Clark Laboratories, Inc. | 1998-05-01 |
| K951549 | EBNA IGG EIA TEST SYSTEM | Immunoprobe, Inc. | 1996-04-29 |
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | Granbio, Inc. | 1996-02-15 |
| K935730 | EBNA IGG ELISA TEST | Gull Laboratories, Inc. | 1995-09-19 |
| K946353 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY | Mrl Diagnostics | 1995-07-21 |
| K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT | Incstar Corp. | 1995-06-09 |
| K932742 | EBNA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1995-05-05 |
| K925690 | MERIDIAN EBNA TEST KIT | Fuller Laboratories, Inc. | 1993-10-12 |
| K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 |
| K911473 | EBNA STAT TEST KIT | Whittaker Bioproducts, Inc. | 1991-09-25 |
| K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | 1991-06-10 |
| K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | Immuno Concepts, Inc. | 1989-12-11 |
| K895707 | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) | Immuno Concepts, Inc. | 1989-12-08 |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | Bion Ent., Ltd. | 1989-10-16 |
| K891542 | EBNA-CHECK(TM) TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | Clinical Sciences, Inc. | 1989-05-11 |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | Clinical Sciences, Inc. | 1989-05-11 |
| K882440 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST | Zeus Scientific, Inc. | 1988-12-15 |
| K875203 | DU PONT EBNA-IGG ANTIBODY ELISA KIT | E.I. Dupont DE Nemours & Co., Inc. | 1988-08-30 |
| K875170 | EBNA ANTIBODY | Hillcrest Biologicals | 1988-05-23 |
| K880043 | EBV-NA TEST | Gull Laboratories, Inc. | 1988-03-24 |
| K871298 | EBNA ACIF ASSAY KIT | Granbio, Inc. | 1987-06-25 |
| K840417 | EBNA ACIF KIT | Litton Bionetics | 1984-12-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00840733101953 | MERIFLUOR EBV-NA | MERIDIAN BIOSCIENCE, INC. | 2020-10-26 |
| 05391516746571 | Bio-Rad Platelia | CLARK LABORATORIES, INC. | 2019-11-07 |
| 05391516743570 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-11-05 |
| 05391516743587 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-11-05 |
| 05391516747097 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-11-05 |
| 05391516747103 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-11-05 |
| B110NA51120 | EBV Nuclear Antigen (EBNA) Substrate, 12 wells, For ACIF Test System | Bion Enterprises, Ltd. | 2016-09-12 |
| B110NA51400 | EBNA Positive Control | Bion Enterprises, Ltd. | 2016-09-12 |