Product code GNP
- Device name
- Antiserum, Cf, 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 |
|---|---|---|---|
| K020707 | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 |
| K020717 | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | Pan Bio Pty. , Ltd. | 2002-06-13 |
| K020706 | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | Pan Bio Pty. , Ltd. | 2002-06-13 |
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 |
| K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 |
| K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | 1990-09-12 |
| K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | Electro-Nucleonics, Inc. | 1989-04-28 |
| K884591 | EBV-VCA ANTIBODY (IGG) | Hillcrest Biologicals | 1989-01-24 |
| K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | 1988-08-30 |
| K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | 1988-08-30 |
| K871373 | EBV-CHECK(TM) TEST KIT (IGG) | Diagnostic Technology, Inc. | 1987-06-25 |
| K861121 | THE GOLDEN QUAD TEST (EBV) | Microbiological Research Corp. | 1987-02-02 |
| K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | Granbio, Inc. | 1987-02-02 |
| K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | Diagnostic Technology, Inc. | 1986-11-28 |
| K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT | Immuno-Diagnostic Products, Inc. | 1986-04-24 |
| K853484 | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT | Biotech Research Laboratories, Inc. | 1986-02-05 |
| K842662 | ANTI-EPSTEIN-BARR VIRUS KIT | Amico Lab, Inc. | 1985-12-12 |
| K842530 | AMIZYME-EBV TEST KIT | Amico Lab, Inc. | 1985-12-06 |
| K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | Electro-Nucleonics Laboratories, Inc. | 1981-05-05 |
| K771062 | EBV TEST | Gull Laboratories, Inc. | 1977-07-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B3507206200 | Gold Standard Diagnostics Is-EBNA-1 IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2022-12-07 |
| B3507206400 | Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit | Gold Standard Diagnostics Corporation | 2022-12-07 |
| 00840733101939 | MERIFLUOR EBV VCA IgG IFA | MERIDIAN BIOSCIENCE, INC. | 2020-09-21 |
| 05391516746557 | Bio-Rad Platelia | CLARK LABORATORIES, INC. | 2019-11-07 |
| 05391516747073 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-10-25 |
| 00817273020358 | Diamedix | DIAMEDIX CORPORATION | 2016-09-20 |