GNP — Antiserum, Cf, Epstein-Barr Virus Class I
FDA product code GNP covers "Antiserum, Cf, Epstein-Barr Virus", a Class I medical device regulated under 21 CFR 866.3235. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GNP
- Device Class
- Class I
- Regulation Number
- 866.3235
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K020717 | pan bio pty. | EBV V VCA IGM ELISA KIT MODEL# EBM-200 | June 13, 2002 |
| K020706 | pan bio pty. | EBV-VCA IGG ELISA TEST, MODEL EBG-100 | June 13, 2002 |
| K020707 | pan bio pty. | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 | June 13, 2002 |
| K981831 | diamedix | IS EBV-EA-D IGG ELISA TEST SYSTEM | February 16, 1999 |
| K981829 | diamedix | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | February 16, 1999 |
| K901156 | granbio | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM | September 12, 1990 |
| K883670 | electro-nucleonics | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI | April 28, 1989 |
| K884591 | hillcrest biologicals | EBV-VCA ANTIBODY (IGG) | January 24, 1989 |
| K880883 | immuno concepts | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) | August 30, 1988 |
| K880885 | immuno concepts | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) | August 30, 1988 |
| K871373 | diagnostic technology | EBV-CHECK(TM) TEST KIT (IGG) | June 25, 1987 |
| K861121 | microbiological research | THE GOLDEN QUAD TEST (EBV) | February 2, 1987 |
| K864347 | granbio | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA | February 2, 1987 |
| K863408 | diagnostic technology | EBV/VCA-CHECK(TM) ANTIGEN SLIDES | November 28, 1986 |
| K854207 | immuno-diagnostic products | EBV(EPSTEIN-BARR VIRUS) TEST KIT | April 24, 1986 |
| K853484 | biotech research laboratories | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT | February 5, 1986 |
| K842662 | amico lab | ANTI-EPSTEIN-BARR VIRUS KIT | December 12, 1985 |
| K842530 | amico lab | AMIZYME-EBV TEST KIT | December 6, 1985 |
| K810860 | electro-nucleonics laboratories | ENI ANTIBODY TO EPSTEIN-BARR VIRUS | May 5, 1981 |
| K771062 | gull laboratories | EBV TEST | July 14, 1977 |