LSE · Class I · 21 CFR 866.3235

FDA Product Code LSE: Epstein-barr Virus, Other

Leading manufacturers include DiaSorin, Inc., Zeus Scientific, Inc. and Whittaker Bioproducts, Inc..

56
Total
56
Cleared
173d
Avg days
1988
Since
56 devices
25–48 of 56
Cleared Aug 21, 1998
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120
Zeus Scientific, Inc.
Microbiology · 147d
Cleared Aug 10, 1998
IMMUNOWELL EBV VCA IGG TEST
K973940
Genbio
Microbiology · 299d
Cleared Jul 22, 1998
VCA IGM ELISA TEST SYSTEM
K980596
Clark Laboratories, Inc.
Microbiology · 155d
Cleared Jul 22, 1998
VCA IGG ELISA TEST SYSTEM
K980912
Clark Laboratories, Inc.
Microbiology · 134d
Cleared Mar 26, 1998
EA-D IGG ELISA TEST SYSTEM
K973123
Clark Laboratories, Inc.
Microbiology · 218d
Cleared Sep 25, 1995
EBV-VCA IGM ELISA TEST STSTEM
K944449
Zeus Scientific, Inc.
Microbiology · 378d
Cleared Sep 15, 1995
EBV-EA(D) IGG ELISA TEST
K940093
Gull Laboratories, Inc.
Microbiology · 616d
Cleared Aug 23, 1995
EBV LGG ELISA TEST
K941198
Gull Laboratories, Inc.
Microbiology · 527d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KIT
K946157
Incstar Corp.
Microbiology · 181d
Cleared Jun 07, 1995
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159
Incstar Corp.
Microbiology · 181d
Cleared Nov 05, 1993
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443
Ortho Diagnostic Systems, Inc.
Microbiology · 228d
Cleared Sep 14, 1992
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628
Incstar Corp.
Microbiology · 161d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332
Baxter Diagnostics, Inc.
Microbiology · 112d
Cleared Jul 24, 1991
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Jul 24, 1991
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912489
Immuno Concepts, Inc.
Microbiology · 50d
Cleared Oct 16, 1990
EBV/EA-CHECK TM TEST KIT
K903612
Diagnostic Technology, Inc.
Microbiology · 68d
Cleared Oct 16, 1989
FIAX EB VCA-M TEST KIT
K894932
Whittaker Bioproducts, Inc.
Microbiology · 74d
Cleared Aug 30, 1989
EB VCA STAT M TEST KIT
K894235
Whittaker Bioproducts, Inc.
Microbiology · 71d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
K883870
Clinical Sciences, Inc.
Microbiology · 304d
Cleared Jul 14, 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590
K883871
Clinical Sciences, Inc.
Microbiology · 304d
Cleared May 10, 1989
STAT TEST KIT FOR EB-VCA IGG ANTIBODY
K891086
Whittaker Bioproducts, Inc.
Microbiology · 70d
Cleared Dec 15, 1988
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447
Zeus Scientific, Inc.
Microbiology · 184d
Cleared Aug 03, 1988
FIAX TEST KIT FOR EB-VCA-G ANTIBODY
K882023
Whittaker Bioproducts, Inc.
Microbiology · 78d
Cleared Jan 05, 1988
EBV-EA TEST
K872617
Gull Laboratories, Inc.
Microbiology · 183d