FDA product code LLM: Test, Antigen, Nuclear, Epstein-Barr Virus
LLM is the FDA product code for test, antigen, nuclear, epstein-barr virus. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. FDA has cleared 27 510(k) submissions under LLM, 1 in the last five years, from 20 different applicants. The average 510(k) review took 234 days (median 193); 272 days on average over the last three years. FDA has posted 1 recall for LLM devices.
Classification
| Field | Value |
|---|---|
| Device name | Test, Antigen, Nuclear, 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 |
510(k) clearances per year for LLM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 272 |
Compare with all 510(k) review times · Search every LLM clearance
Top LLM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeus Scientific, Inc. | 3 | 1999-01-11 |
| Granbio, Inc. | 2 | 1996-02-15 |
| Gull Laboratories, Inc. | 2 | 1995-09-19 |
| Ortho Diagnostic Systems, Inc. | 2 | 1993-07-16 |
| Immuno Concepts, Inc. | 2 | 1989-12-11 |
15 more applicants have LLM clearances. See the full list in Caduvo.
Most recent LLM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233605 | Biokit, S.A. | ADVIA Centaur EBV-EBNA IgG | 2024-08-07 | 272 |
| K040120 | DiaSorin, Inc. | DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS | 2005-04-29 | 465 |
| K984133 | Zeus Scientific, Inc. | THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH | 1999-01-11 | 54 |
| K973941 | Genbio | IMMUNOWELL EBNA IGG TEST | 1998-08-10 | 299 |
| K980598 | Clark Laboratories, Inc. | EBNA-1 IGM ELISA TEST SYSTEM | 1998-05-01 | 73 |
Recalls for LLM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2007-03-14.
Frequently asked questions
What is FDA product code LLM?
LLM is the FDA product code for test, antigen, nuclear, 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 LLM?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
How long does a 510(k) take for product code LLM?
Across 27 cleared submissions the average was 234 days from receipt to decision (median 193).
Which companies have the most LLM clearances?
Zeus Scientific, Inc. (3); Granbio, Inc. (2); Gull Laboratories, Inc. (2); Ortho Diagnostic Systems, Inc. (2); Immuno Concepts, Inc. (2).
Have LLM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2007-03-14.
Next steps
- Run an FDA pathway report with predicate devices for product code LLM
- Run a recall and safety report across every LLM manufacturer
- Watch product code LLM 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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