Panels › Microbiology › Product code GNP · Class 1
Antiserum, Cf, Epstein-Barr Virus
Regulation 866.3235
0510(k)s in 12 months (20 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GNP
| Company | 510(k)s | Recalls |
|---|---|---|
| Diamedix Corp. | 2 | 2 |
| Pan Bio Pty. , Ltd. | 3 | 0 |
| Amico Lab, Inc. | 2 | 0 |
| Diagnostic Technology, Inc. | 2 | 0 |
| Granbio, Inc. | 2 | 0 |
| Immuno Concepts, Inc. | 2 | 0 |
| Biotech Research Laboratories, Inc. | 1 | 0 |
| Electro-Nucleonics, Inc. | 1 | 0 |
| Electro-Nucleonics Laboratories, Inc. | 1 | 0 |
| Gull Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 13, 2002 | K020717 | EBV V VCA IGM ELISA KIT MODEL# EBM-200 Pan Bio Pty. , Ltd., AU | GNP |
| Jun 13, 2002 | K020707 | EBV-EBNA IGG ELISA KIT, MODEL EBG-100 Pan Bio Pty. , Ltd., AU | GNP |
| Jun 13, 2002 | K020706 | EBV-VCA IGG ELISA TEST, MODEL EBG-100 Pan Bio Pty. , Ltd., AU | GNP |
| Feb 16, 1999 | K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM Diamedix Corp. | GNP |
| Feb 16, 1999 | K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM Diamedix Corp. | GNP |
| Sep 12, 1990 | K901156 | EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM Granbio, Inc. | GNP |
| Apr 28, 1989 | K883670 | SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI Electro-Nucleonics, Inc. | GNP |
| Jan 24, 1989 | K884591 | EBV-VCA ANTIBODY (IGG) Hillcrest Biologicals | GNP |
| Aug 30, 1988 | K880885 | EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) Immuno Concepts, Inc. | GNP |
| Aug 30, 1988 | K880883 | EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) Immuno Concepts, Inc. | GNP |
| Jun 25, 1987 | K871373 | EBV-CHECK(TM) TEST KIT (IGG) Diagnostic Technology, Inc. | GNP |
| Feb 2, 1987 | K864347 | INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA Granbio, Inc. | GNP |
| Feb 2, 1987 | K861121 | THE GOLDEN QUAD TEST (EBV) Microbiological Research Corp. | GNP |
| Nov 28, 1986 | K863408 | EBV/VCA-CHECK(TM) ANTIGEN SLIDES Diagnostic Technology, Inc. | GNP |
| Apr 24, 1986 | K854207 | EBV(EPSTEIN-BARR VIRUS) TEST KIT Immuno-Diagnostic Products, Inc. | GNP |
| Feb 5, 1986 | K853484 | INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT Biotech Research Laboratories, Inc. | GNP |
| Dec 12, 1985 | K842662 | ANTI-EPSTEIN-BARR VIRUS KIT Amico Lab, Inc. | GNP |
| Dec 6, 1985 | K842530 | AMIZYME-EBV TEST KIT Amico Lab, Inc. | GNP |
| May 5, 1981 | K810860 | ENI ANTIBODY TO EPSTEIN-BARR VIRUS Electro-Nucleonics Laboratories, Inc. | GNP |
| Jul 14, 1977 | K771062 | EBV TEST Gull Laboratories, Inc. | GNP |
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