Antibody Igm, If, Epstein-Barr Virus
FDA product code LJN · Class I (low risk) · 21 CFR 866.3235 · Microbiology
23510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Granbio, Inc. 2
- Ortho Diagnostic Systems, Inc. 2
- Zeus Scientific, Inc. 2
- Immuno Concepts, Inc. 2
- Quest Intl., Inc. 2
- Bio-Rad Laboratories, Inc. 1
- Focus Diagnostics, Inc. 1
- DiaSorin, Inc. 1
- Genbio 1
- Mrl Diagnostics 1
- Baxter Diagnostics, Inc. 1
- Pharmacia Diagnostics, Inc. 1
- Amico Laboratories, Inc. 1
- Gull Laboratories, Inc. 1
- Hillcrest Biologicals 1
- Bion Ent., Ltd. 1
- Diagnostic Technology, Inc. 1
- E.I. Dupont DE Nemours & Co., Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123021 | Bioplex 2200 Ebv Igm KitLJN · Traditional | Bio-Rad Laboratories | 11/02/2012SE |
| K073381 | Plexus Ebv Igm Multi-Analyte Diagnostics, Model: MP0600MLJN · Traditional | Focus Diagnostics, Inc. | 08/04/2008SE |
| K042092 | Athena Multi-Lyte Ebv Vca Igm Test SystemLJN · Traditional | Zeus Scientific, Inc. | 04/12/2005SE |
| K033780 | Modification to Seraquest Vca IgmLJN · Special | Quest Intl., Inc. | 01/15/2004SE |
| K990977 | Seraquest Eb Vac IgmLJN · Traditional | Quest Intl., Inc. | 10/06/1999SE |
| K991459 | Copalis Ebv-M Antibody AssayLJN · Traditional | DiaSorin, Inc. | 05/14/1999SE |
| K973939 | Immunowell Vca Igm TestLJN · Traditional | Genbio | 08/10/1998SE |
| K931520 | Epstein-Barr Virus Vca (Igm) Recomb Immun AntibodyLJN · Traditional | Mrl Diagnostics | 04/26/1994SE |
| K930020 | Ortho*Epstein-Barr Virus Vca-Igm Antibody ElisaLJN · Traditional | Ortho Diagnostic Systems, Inc. | 07/16/1993SE |
| K922331 | Bartels Epstein-Barr Virus Igm EiaLJN · Traditional | Baxter Diagnostics, Inc. | 09/02/1992SE |
| K915348 | Ebv-Vca Igm ElisaLJN · Traditional | Pharmacia Diagnostics, Inc. | 02/14/1992SE |
| K911362 | Amizyme Epstein-Barr Virus (Ebv) Igm Antibody TestLJN · Traditional | Amico Laboratories, Inc. | 10/07/1991SE |
| K910042 | Ebv Igm Elisa TestLJN · Traditional | Gull Laboratories, Inc. | 02/21/1991SE |
| K901840 | (Eia) for Igm Antibody to Ebv Vca in Human SerumLJN · Traditional | Granbio, Inc. | 09/12/1990SE |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | Hillcrest Biologicals | 01/16/1990SE |
| K893240 | Bion Ebv-M (Vca) Test SystemLJN · Traditional | Bion Ent., Ltd. | 07/14/1989SE |
| K890639 | Resubmitted Ebv/Igm-Check Test KitLJN · Traditional | Diagnostic Technology, Inc. | 06/20/1989SE |
| K880886 | Ebv-Vca Igm Antibody Test System (Fluorescent)LJN · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
| K880884 | Ebv-Vca Igm Antibody Test System (Enzyme)LJN · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
| K875204 | Du Pont Vca-Igm Antibody Elisa KitLJN · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 07/08/1988SE |
| K872541 | Ortho Monolert* Rapid Elisa Test for Infect. Mono.LJN · Traditional | Ortho Diagnostic Systems, Inc. | 05/13/1988SE |
| K864604 | Ebv Vca Igm Antibody Assay KitLJN · Traditional | Granbio, Inc. | 02/02/1987SE |
| K833014 | Ebv-Vca-Igm Ifa Test SystemLJN · Traditional | Zeus Scientific, Inc. | 12/27/1983SE |