Test, Antigen, Nuclear, Epstein-Barr Virus
FDA product code LLM · Class I (low risk) · 21 CFR 866.3235 · Microbiology
27510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Zeus Scientific, Inc. 3
- Granbio, Inc. 2
- Ortho Diagnostic Systems, Inc. 2
- Immuno Concepts, Inc. 2
- Clinical Sciences, Inc. 2
- Gull Laboratories, Inc. 2
- E.I. Dupont DE Nemours & Co., Inc. 1
- Hillcrest Biologicals 1
- Diagnostic Technology, Inc. 1
- Bion Ent., Ltd. 1
- Litton Bionetics 1
- Whittaker Bioproducts, Inc. 1
- Fuller Laboratories, Inc. 1
- Incstar Corp. 1
- Mrl Diagnostics 1
- Immunoprobe, Inc. 1
- Clark Laboratories, Inc. 1
- Genbio 1
- DiaSorin, Inc. 1
- Biokit, S.A. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgGLLM · Traditional | Biokit, S.A. | 08/07/2024SE |
| K040120 | Diasorin Liaison Ebna Igg, Liaison Vca Igg, Liaison Vca Igm AssaysLLM · Traditional | DiaSorin, Inc. | 04/29/2005SE |
| K984133 | The Aptus (Automated) Application of the Ebna Igg Elisa Test System. an Enzyme Linked…LLM · Traditional | Zeus Scientific, Inc. | 01/11/1999SE |
| K973941 | Immunowell Ebna Igg TestLLM · Traditional | Genbio | 08/10/1998SE |
| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | Clark Laboratories, Inc. | 05/01/1998SE |
| K951549 | Ebna Igg Eia Test SystemLLM · Traditional | Immunoprobe, Inc. | 04/29/1996SE |
| K951822 | Ebna Enzyme Immunoassay KitLLM · Traditional | Granbio, Inc. | 02/15/1996SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | Gull Laboratories, Inc. | 09/19/1995SE |
| K946353 | Epstein-Barr Virus Nuclear Antigen Recombinant Immunofluorescent AssayLLM · Traditional | Mrl Diagnostics | 07/21/1995SE |
| K946158 | Incstar Epstein-Barr Nuclear Antigen (Ebna_ Igg Elisa KitLLM · Traditional | Incstar Corp. | 06/09/1995SE |
| K932742 | Ebna Igg Elisa Test SystemLLM · Traditional | Zeus Scientific, Inc. | 05/05/1995SE |
| K925690 | Meridian Ebna Test KitLLM · Traditional | Fuller Laboratories, Inc. | 10/12/1993SE |
| K930002 | Ortho*Epstein-Barr Virus Ebna-Iff Antibody ElisaLLM · Traditional | Ortho Diagnostic Systems, Inc. | 07/16/1993SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | Whittaker Bioproducts, Inc. | 09/25/1991SE |
| K911569 | Epstein-Barr Virus Ebna-Igg Antibody Elisa TestLLM · Traditional | Ortho Diagnostic Systems, Inc. | 06/10/1991SE |
| K895708 | Ebna Antibody Test System (Immunofluorescent Anti)LLM · Traditional | Immuno Concepts, Inc. | 12/11/1989SE |
| K895707 | Ebna Antibody Test System (Immunoenzyme Antibody)LLM · Traditional | Immuno Concepts, Inc. | 12/08/1989SE |
| K894626 | Epstein-Barr Virus-Nuclear AntigenLLM · Traditional | Bion Ent., Ltd. | 10/16/1989SE |
| K891542 | Ebna-Check(Tm) Test KitLLM · Traditional | Diagnostic Technology, Inc. | 06/20/1989SE |
| K883601 | Epstein-Barr Virus (EBNA-1) Igm Cata. #5550LLM · Traditional | Clinical Sciences, Inc. | 05/11/1989SE |
| K883600 | Epstein-Barr Virus (EBNA-1) Igg Cata. #4550LLM · Traditional | Clinical Sciences, Inc. | 05/11/1989SE |
| K882440 | Epstein-Barr Virus Nuclear Antigen Antibody TestLLM · Traditional | Zeus Scientific, Inc. | 12/15/1988SE |
| K875203 | Du Pont Ebna-Igg Antibody Elisa KitLLM · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 08/30/1988SE |
| K875170 | Ebna AntibodyLLM · Traditional | Hillcrest Biologicals | 05/23/1988SE |
| K880043 | Ebv-Na TestLLM · Traditional | Gull Laboratories, Inc. | 03/24/1988SE |
| K871298 | Ebna Acif Assay KitLLM · Traditional | Granbio, Inc. | 06/25/1987SE |
| K840417 | Ebna Acif KitLLM · Traditional | Litton Bionetics | 12/27/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0755-2007 | DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative…A lot to lot inconsistency was noted on kits of ETI EBNA G. | Diasorin Inc. | 03/14/2007Terminated |