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 |