FDA Product Code
FDA Product Code LJN — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3235
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260233 | Elecsys EBV IgM | Roche Diagnostics | 2026-10-02 | Traditional | PDF ↗ |
| K123021 | BIOPLEX 2200 EBV IGM KIT | Bio-Rad Laboratories | 2012-11-02 | Traditional | PDF ↗ |
| K073381 | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | Focus Diagnostics, Inc. | 2008-08-04 | Traditional | PDF ↗ |
| K042092 | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | Zeus Scientific, Inc. | 2005-04-12 | Traditional | PDF ↗ |
| K033780 | MODIFICATION TO SERAQUEST VCA IGM | Quest Intl., Inc. | 2004-01-15 | Special | PDF ↗ |
| K990977 | SERAQUEST EB VAC IGM | Quest Intl., Inc. | 1999-10-06 | Traditional | PDF ↗ |
| K991459 | COPALIS EBV-M ANTIBODY ASSAY | DiaSorin, Inc. | 1999-05-14 | Traditional | PDF ↗ |
| K973939 | IMMUNOWELL VCA IGM TEST | Genbio | 1998-08-10 | Traditional | PDF ↗ |
| K931520 | EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY | Mrl Diagnostics | 1994-04-26 | Traditional | PDF ↗ |
| K930020 | ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA | Ortho Diagnostic Systems, Inc. | 1993-07-16 | Traditional | PDF ↗ |
| K922331 | BARTELS EPSTEIN-BARR VIRUS IGM EIA | Baxter Diagnostics, Inc. | 1992-09-02 | Traditional | PDF ↗ |
| K915348 | EBV-VCA IGM ELISA | Pharmacia Diagnostics, Inc. | 1992-02-14 | Traditional | PDF ↗ |
| K911362 | AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST | Amico Laboratories, Inc. | 1991-10-07 | Traditional | PDF ↗ |
| K910042 | EBV IGM ELISA TEST | Gull Laboratories, Inc. | 1991-02-21 | Traditional | PDF ↗ |
| K901840 | (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM | Granbio, Inc. | 1990-09-12 | Traditional | PDF ↗ |
| K896594 | EBV VCA ANTIBODY (IGM) | Hillcrest Biologicals | 1990-01-16 | Traditional | PDF ↗ |
| K893240 | BION EBV-M (VCA) TEST SYSTEM | Bion Ent., Ltd. | 1989-07-14 | Traditional | PDF ↗ |
| K890639 | RESUBMITTED EBV/IGM-CHECK TEST KIT | Diagnostic Technology, Inc. | 1989-06-20 | Traditional | PDF ↗ |
| K880886 | EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) | Immuno Concepts, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K880884 | EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) | Immuno Concepts, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K875204 | DU PONT VCA-IGM ANTIBODY ELISA KIT | E.I. Dupont DE Nemours & Co., Inc. | 1988-07-08 | Traditional | PDF ↗ |
| K872541 | ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. | Ortho Diagnostic Systems, Inc. | 1988-05-13 | Traditional | PDF ↗ |
| K864604 | EBV VCA IGM ANTIBODY ASSAY KIT | Granbio, Inc. | 1987-02-02 | Traditional | PDF ↗ |
| K833014 | EBV-VCA-IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | 1983-12-27 | Traditional | PDF ↗ |
Product code LJN · Class I · Microbiology. Data: openFDA.