FDA product code LSE: Epstein-Barr Virus, Other
LSE is the FDA product code for epstein-barr virus, other. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. FDA has cleared 56 510(k) submissions under LSE, 1 in the last five years, from 25 different applicants. The average 510(k) review took 173 days (median 143); 272 days on average over the last three years. FDA has posted 7 recalls for LSE devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Epstein-Barr Virus, Other |
| 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 LSE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 72 |
| 2024 | 1 | 272 |
Compare with all 510(k) review times · Search every LSE clearance
Top LSE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| DiaSorin, Inc. | 5 | 2017-01-05 |
| Zeus Scientific, Inc. | 5 | 1998-12-10 |
| Quest Intl., Inc. | 4 | 2009-06-08 |
| Genbio | 4 | 2001-06-11 |
| Whittaker Bioproducts, Inc. | 4 | 1989-10-16 |
20 more applicants have LSE clearances. See the full list in Caduvo.
Most recent LSE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233606 | Biokit, S.A. | ADVIA Centaur EBV-VCA IgM | 2024-08-07 | 272 |
| K162961 | DiaSorin, Inc. | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set | 2017-01-05 | 73 |
| K162959 | DiaSorin, Inc. | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | 2017-01-04 | 72 |
| K091260 | Quest Intl., Inc. | SERAQUEST EBV EA-D IGG TEST | 2009-06-08 | 40 |
| K073382 | Focus Diagnostics, Inc. | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | 2008-07-28 | 238 |
Recalls for LSE devices
7 product recalls in 6 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-11-03.
| Year | Recalls |
|---|---|
| 2025 | 1 |
Frequently asked questions
What is FDA product code LSE?
LSE is the FDA product code for epstein-barr virus, other. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel.
What device class is LSE?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
How long does a 510(k) take for product code LSE?
Across 56 cleared submissions the average was 173 days from receipt to decision (median 143).
Which companies have the most LSE clearances?
DiaSorin, Inc. (5); Zeus Scientific, Inc. (5); Quest Intl., Inc. (4); Genbio (4); Whittaker Bioproducts, Inc. (4).
Have LSE devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2025-11-03.
Next steps
- Run an FDA pathway report with predicate devices for product code LSE
- Run a recall and safety report across every LSE manufacturer
- Watch product code LSE 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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