Panels › Microbiology › Product code LJN · Class 1
Antibody Igm, If, Epstein-Barr Virus
Regulation 866.3235
1510(k)s in 12 months (24 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LJN
| Company | 510(k)s | Recalls |
|---|---|---|
| Granbio, Inc. | 2 | 0 |
| Immuno Concepts, Inc. | 2 | 0 |
| Ortho Diagnostic Systems, Inc. | 2 | 0 |
| Quest Intl., Inc. | 2 | 0 |
| Zeus Scientific, Inc. | 2 | 0 |
| Amico Laboratories, Inc. | 1 | 0 |
| Baxter Diagnostics, Inc. | 1 | 0 |
| Bio-Rad Laboratories | 1 | 0 |
| Bion Ent., Ltd. | 1 | 0 |
| Diagnostic Technology, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K260233 | Elecsys EBV IgM Roche Diagnostics | LJN |
| Nov 2, 2012 | K123021 | BIOPLEX 2200 EBV IGM KIT Bio-Rad Laboratories | LJN |
| Aug 4, 2008 | K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M Focus Diagnostics, Inc. | LJN |
| Apr 12, 2005 | K042092 | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM Zeus Scientific, Inc. | LJN |
| Jan 15, 2004 | K033780 | MODIFICATION TO SERAQUEST VCA IGM Quest Intl., Inc. | LJN |
| Oct 6, 1999 | K990977 | SERAQUEST EB VAC IGM Quest Intl., Inc. | LJN |
| May 14, 1999 | K991459 | COPALIS EBV-M ANTIBODY ASSAY DiaSorin, Inc. | LJN |
| Aug 10, 1998 | K973939 | IMMUNOWELL VCA IGM TEST Genbio | LJN |
| Apr 26, 1994 | K931520 | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY Mrl Diagnostics | LJN |
| Jul 16, 1993 | K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA Ortho Diagnostic Systems, Inc. | LJN |
| Sep 2, 1992 | K922331 | BARTELS EPSTEIN-BARR VIRUS IGM EIA Baxter Diagnostics, Inc. | LJN |
| Feb 14, 1992 | K915348 | EBV-VCA IGM ELISA Pharmacia Diagnostics, Inc. | LJN |
| Oct 7, 1991 | K911362 | AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST Amico Laboratories, Inc. | LJN |
| Feb 21, 1991 | K910042 | EBV IGM ELISA TEST Gull Laboratories, Inc. | LJN |
| Sep 12, 1990 | K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM Granbio, Inc. | LJN |
| Jan 16, 1990 | K896594 | EBV VCA ANTIBODY (IGM) Hillcrest Biologicals | LJN |
| Jul 14, 1989 | K893240 | BION EBV-M (VCA) TEST SYSTEM Bion Ent., Ltd. | LJN |
| Jun 20, 1989 | K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT Diagnostic Technology, Inc. | LJN |
| Aug 30, 1988 | K880886 | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) Immuno Concepts, Inc. | LJN |
| Aug 30, 1988 | K880884 | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) Immuno Concepts, Inc. | LJN |
| Jul 8, 1988 | K875204 | DU PONT VCA-IGM ANTIBODY ELISA KIT E.I. Dupont DE Nemours & Co., Inc. | LJN |
| May 13, 1988 | K872541 | ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. Ortho Diagnostic Systems, Inc. | LJN |
| Feb 2, 1987 | K864604 | EBV VCA IGM ANTIBODY ASSAY KIT Granbio, Inc. | LJN |
| Dec 27, 1983 | K833014 | EBV-VCA-IGM IFA TEST SYSTEM Zeus Scientific, Inc. | LJN |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.