LSEClass I
Epstein-Barr Virus, Other
21 CFR 866.3235 / Microbiology
LSE is the FDA product code for Epstein-Barr Virus, Other, a class I device type, regulated under 21 CFR 866.3235. As of , FDA records hold 56 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- LSE
- Device name
- Epstein-Barr Virus, Other
- Regulation
- 21 CFR 866.3235
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 56
- Ingested recalls
- 7
Clearances, product code LSE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1988 | 4 |
| 1989 | 6 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 1 |
| 1995 | 5 |
| 1998 | 12 |
| 1999 | 9 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2006 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2017 | 2 |
| 2024 | 1 |
Applicants with the most clearances
Product code LSE| Applicant | Clearances |
|---|---|
| Diasorin Inc. | 5 |
| Zeus Scientific LLC | 5 |
| Genbio | 4 |
| Quest Intl., Inc. | 4 |
| Whittaker Bioproducts, Inc. | 4 |
| Biotest Diagnostics Corp. | 3 |
| Trinity Biotech USA | 3 |
| Columbia Bioscience, Inc. | 3 |
| Gull Laboratories, Inc. | 3 |
| Incstar Corp. | 3 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.