FDA product code LJN: Antibody Igm, If, Epstein-Barr Virus
LJN is the FDA product code for antibody igm, if, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. FDA has cleared 23 510(k) submissions under LJN, from 18 different applicants. The average 510(k) review took 156 days (median 141).
Classification
| Field | Value |
|---|---|
| Device name | Antibody Igm, If, Epstein-Barr Virus |
| Device class | Class I |
| Regulation | 21 CFR 866.3235 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LJN clearance
Top LJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 2 | 2005-04-12 |
| Quest Intl., Inc. | 2 | 2004-01-15 |
| Ortho Diagnostic Systems, Inc. | 2 | 1993-07-16 |
| Granbio, Inc. | 2 | 1990-09-12 |
| Immuno Concepts, Inc. | 2 | 1988-08-30 |
13 more applicants have LJN clearances. See the full list in Caduvo.
Most recent LJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123021 | Bio-Rad Laboratories | BIOPLEX 2200 EBV IGM KIT | 2012-11-02 | 36 |
| K073381 | Focus Diagnostics, Inc. | PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M | 2008-08-04 | 245 |
| K042092 | Zeus Scientific, Inc. | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM | 2005-04-12 | 252 |
| K033780 | Quest Intl., Inc. | MODIFICATION TO SERAQUEST VCA IGM | 2004-01-15 | 42 |
| K990977 | Quest Intl., Inc. | SERAQUEST EB VAC IGM | 1999-10-06 | 197 |
Recalls for LJN devices
openFDA lists no recalls for product code LJN.
Frequently asked questions
What is FDA product code LJN?
LJN is the FDA product code for antibody igm, if, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel.
What device class is LJN?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
How long does a 510(k) take for product code LJN?
Across 23 cleared submissions the average was 156 days from receipt to decision (median 141).
Which companies have the most LJN clearances?
Zeus Scientific, Inc. (2); Quest Intl., Inc. (2); Ortho Diagnostic Systems, Inc. (2); Granbio, Inc. (2); Immuno Concepts, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LJN
- Run a recall and safety report across every LJN manufacturer
- Watch product code LJN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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