Test, Antigen, Nuclear, Epstein-Barr Virus
Test, Antigen, Nuclear, Epstein-Barr Virus is a diagnostic test used to detect the Epstein-Barr Virus Nuclear Antigen (EBNA), which appears in infected cells following EBV infection and whose presence indicates past rather than acute EBV infection, aiding in the serological staging of EBV-related disease. This device is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is LLM, regulated under 21 CFR 866.3235, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.
Basic Information
- Product Code
- LLM
- Device Class
- FDA class 1
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 27 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233605 | ADVIA Centaur EBV-EBNA IgG | Aug 07, 2024 | Substantially Equivalent | Biokit S.A. |
| K040120 | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS | Apr 29, 2005 | Substantially Equivalent | DIASORIN, INC. |
| K984133 | THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | Jan 11, 1999 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K973941 | IMMUNOWELL EBNA IGG TEST | Aug 10, 1998 | Substantially Equivalent | GenBio |
| K980598 | EBNA-1 IGM ELISA TEST SYSTEM | May 01, 1998 | Substantially Equivalent | CLARK LABORATORIES, INC. |
| K951549 | EBNA IGG EIA TEST SYSTEM | Apr 29, 1996 | Substantially Equivalent | IMMUNO PROBE, INC. |
| K951822 | EBNA ENZYME IMMUNOASSAY KIT | Feb 15, 1996 | Substantially Equivalent | GRANBIO, INC. |
| K935730 | EBNA IGG ELISA TEST | Sep 19, 1995 | Substantially Equivalent | GULL LABORATORIES, INC. |
| K946353 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY | Jul 21, 1995 | Substantially Equivalent | MRL DIAGNOSTICS |
| K946158 | INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT | Jun 09, 1995 | Substantially Equivalent | INCSTAR CORP. |
| K932742 | EBNA IGG ELISA TEST SYSTEM | May 05, 1995 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K925690 | MERIDIAN EBNA TEST KIT | Oct 12, 1993 | Substantially Equivalent | FULLER LABORATORIES, INC. |
| K930002 | ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA | Jul 16, 1993 | Substantially Equivalent | ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K911473 | EBNA STAT TEST KIT | Sep 25, 1991 | Substantially Equivalent | WHITTAKER BIOPRODUCTS, INC. |
| K911569 | EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST | Jun 10, 1991 | Substantially Equivalent | ORTHO DIAGNOSTIC SYSTEMS, INC. |
| K895708 | EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI) | Dec 11, 1989 | Substantially Equivalent | IMMUNO CONCEPTS, INC. |
| K895707 | EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY) | Dec 08, 1989 | Substantially Equivalent | IMMUNO CONCEPTS, INC. |
| K894626 | EPSTEIN-BARR VIRUS-NUCLEAR ANTIGEN | Oct 16, 1989 | Substantially Equivalent | BION ENT., LTD. |
| K891542 | EBNA-CHECK(TM) TEST KIT | Jun 20, 1989 | Substantially Equivalent | DIAGNOSTIC TECHNOLOGY, INC. |
| K883601 | EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550 | May 11, 1989 | Substantially Equivalent | CLINICAL SCIENCES, INC. |
| K883600 | EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 | May 11, 1989 | Substantially Equivalent | CLINICAL SCIENCES, INC. |
| K882440 | EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST | Dec 15, 1988 | Substantially Equivalent | ZEUS SCIENTIFIC, INC. |
| K875203 | DU PONT EBNA-IGG ANTIBODY ELISA KIT | Aug 30, 1988 | Substantially Equivalent | E.I. DUPONT DE NEMOURS & CO., INC. |
| K875170 | EBNA ANTIBODY | May 23, 1988 | Substantially Equivalent | HILLCREST BIOLOGICALS |
| K880043 | EBV-NA TEST | Mar 24, 1988 | Substantially Equivalent | GULL LABORATORIES, INC. |
| K871298 | EBNA ACIF ASSAY KIT | Jun 25, 1987 | Substantially Equivalent | GRANBIO, INC. |
| K840417 | EBNA ACIF KIT | Dec 27, 1984 | Substantially Equivalent | LITTON BIONETICS |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.