LSE — Epstein-Barr Virus, Other Class I
FDA product code LSE covers "Epstein-Barr Virus, Other", a Class I medical device regulated under 21 CFR 866.3235. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LSE
- Device Class
- Class I
- Regulation Number
- 866.3235
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233606 | biokit | ADVIA Centaur EBV-VCA IgM | August 7, 2024 |
| K162961 | diasorin | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and L | January 5, 2017 |
| K162959 | diasorin | LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set | January 4, 2017 |
| K091260 | quest intl | SERAQUEST EBV EA-D IGG TEST | June 8, 2009 |
| K073382 | focus diagnostics | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | July 28, 2008 |
| K062213 | bio-rad laboratories | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | December 8, 2006 |
| K062211 | bio-rad laboratories | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | December 8, 2006 |
| K060204 | diasorin | LIAISON EA IGG | October 18, 2006 |
| K033915 | quest intl | MODIFICATION TO SERAQUEST EB VCA IGG | January 16, 2004 |
| K030863 | panbio limited | EBV VCA-P18 IGG ELISA | June 27, 2003 |
| K021793 | pan bio pty. | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | September 27, 2002 |
| K010301 | genbio | IMMUNOWELL EA (D) IGG TEST | June 11, 2001 |
| K992587 | stellar bio systems | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | December 22, 1999 |
| K991975 | quest intl | SERAQUEST EB NA IGG | November 2, 1999 |
| K990410 | quest intl | SERAQUEST EB VCA IGG | October 28, 1999 |
| K992191 | diasorin | ETI-EA-G ASSAY | July 12, 1999 |
| K983842 | biotest diagnostics | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | June 9, 1999 |
| K983841 | biotest diagnostics | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | June 9, 1999 |
| K983839 | biotest diagnostics | BIOTEST ANTI-EBV RECOMBINANT | June 9, 1999 |
| K991660 | diasorin | COPALIS MULTIPLEX EBV ANTIBODY ASSAY | June 4, 1999 |