FDA 510(k) Applications for Medical Device Product Code "LSE"
(Epstein-Barr Virus, Other)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K062211 | BIO-RAD LABORATORIES, INC. | BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | 12/08/2006 |
| K062213 | BIO-RAD LABORATORIES, INC. | BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM | 12/08/2006 |
| K983839 | BIOTEST DIAGNOSTICS CORP. | BIOTEST ANTI-EBV RECOMBINANT | 06/09/1999 |
| K983842 | BIOTEST DIAGNOSTICS CORP. | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | 06/09/1999 |
| K983841 | BIOTEST DIAGNOSTICS CORP. | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | 06/09/1999 |
| K973123 | CLARK LABORATORIES, INC. | EA-D IGG ELISA TEST SYSTEM | 03/26/1998 |
| K980912 | CLARK LABORATORIES, INC. | VCA IGG ELISA TEST SYSTEM | 07/22/1998 |
| K980596 | CLARK LABORATORIES, INC. | VCA IGM ELISA TEST SYSTEM | 07/22/1998 |
| K982350 | COLUMBIA BIOSCIENCE, INC. | EA-D IGM ELISA TEST SYSTEM | 11/25/1998 |
| K982348 | COLUMBIA BIOSCIENCE, INC. | EBNA-1 IGM ELISA TEST SYSTEM | 11/25/1998 |
| K982352 | COLUMBIA BIOSCIENCE, INC. | VCA IGM ELISA TEST SYSTEM | 11/25/1998 |
| K981812 | DIAMEDIX CORP. | EBV-VCA IGG ELISA TEST SYSTEM | 03/04/1999 |
| K162959 | DIASORIN INC. | LIAISON« EA IgG and LIAISON« EA IgG Serum Control Set | 01/04/2017 |
| K162961 | DIASORIN INC. | LIAISON« VCA IgG and LIAISON« VCA IgG Serum Control Set; LIAISON« EBNA IgG and LIAISON« EBNA IgG Serum Control Set | 01/05/2017 |
| K991660 | DIASORIN, INC. | COPALIS MULTIPLEX EBV ANTIBODY ASSAY | 06/04/1999 |
| K992191 | DIASORIN, INC. | ETI-EA-G ASSAY | 07/12/1999 |
| K060204 | DIASORIN, INC. | LIAISON EA IGG | 10/18/2006 |
| K073382 | FOCUS DIAGNOSTICS, INC. | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G | 07/28/2008 |
| K974226 | GenBio | IMMUNODOT MONO-G TEST | 09/22/1998 |
| K974244 | GenBio | IMMUNODOT MONO-M TEST | 09/22/1998 |
| K010301 | GenBio | IMMUNOWELL EA (D) IGG TEST | 06/11/2001 |
| K973940 | GenBio | IMMUNOWELL EBV VCA IGG TEST | 08/10/1998 |
| K021793 | PAN BIO PTY. LTD. | EBV EA-D IGG ELISA KIT, MODEL EBG-100 | 09/27/2002 |
| K030863 | PANBIO LIMITED | EBV VCA-P18 IGG ELISA | 06/27/2003 |
| K033915 | QUEST INTL., INC. | MODIFICATION TO SERAQUEST EB VCA IGG | 01/16/2004 |
| K991975 | QUEST INTL., INC. | SERAQUEST EB NA IGG | 11/02/1999 |
| K990410 | QUEST INTL., INC. | SERAQUEST EB VCA IGG | 10/28/1999 |
| K091260 | QUEST INTL., INC. | SERAQUEST EBV EA-D IGG TEST | 06/08/2009 |
| K992587 | STELLAR BIO SYSTEMS, INC. | EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM | 12/22/1999 |
| K983804 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | 12/08/1998 |
| K983801 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO | 12/10/1998 |
| K981120 | ZEUS SCIENTIFIC, INC. | ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA | 08/21/1998 |
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