LFX · Class II · 21 CFR 866.3510

FDA Product Code LFX: Enzyme Linked Immunoabsorbent Assay, Rubella

Leading manufacturers include Abbott Laboratories, Zeus Scientific, Inc. and Gull Laboratories, Inc..

94
Total
94
Cleared
172d
Avg days
1979
Since
94 devices
25–48 of 94
Cleared Dec 20, 1996
RUBASCAN CARD TEST
K952721
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 554d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG FAST ELISA ASSAY
K960358
Incstar Corp.
Microbiology · 273d
Cleared Oct 24, 1996
INCSTAR RUBELLA IGG ELISA ASSAY
K960367
Incstar Corp.
Microbiology · 273d
Cleared Sep 24, 1996
AXSYM RUBELLA IGG ANTIBODY ASSAY
K954045
Abbott Laboratories
Microbiology · 392d
Cleared Sep 04, 1996
SERAQUEST RUBELLA IGG
K961053
Quest Intl., Inc.
Microbiology · 170d
Cleared Jul 16, 1996
IMX RUBELLA IGG
K951541
Abbott Laboratories
Microbiology · 470d
Cleared May 14, 1996
ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY
K954318
Abbott Laboratories
Microbiology · 242d
Cleared Apr 15, 1996
RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE
K951359
Bayer Corp.
Microbiology · 385d
Cleared Apr 09, 1996
ACCESS RUBELLA IGG
K954687
Bio-Rad Laboratories, Inc.
Microbiology · 181d
Cleared Aug 04, 1995
RUBELLA IGG ELISA TEST
K941624
Gull Laboratories, Inc.
Microbiology · 487d
Cleared Dec 19, 1994
IMX RUBELLA IGM ANTIBODY ASSAY
K931059
Abbott Laboratories
Microbiology · 658d
Cleared Sep 17, 1992
BARTELS RUBELLA IGM EIA
K922581
Baxter Diagnostics, Inc.
Microbiology · 113d
Cleared Sep 17, 1992
BARTELS RUBELLA IGG EIA
K922586
Baxter Diagnostics, Inc.
Microbiology · 113d
Cleared Apr 22, 1992
RUBELLA IGM ELISA TEST SYSTEM
K914028
Zeus Scientific, Inc.
Microbiology · 225d
Cleared Mar 04, 1992
RUBELLA IGG ELISA TEST
K915893
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Dec 27, 1991
ELISA RUBELLA IGM
K914420
Sclavo, Inc.
Microbiology · 85d
Cleared Apr 29, 1991
RUBENOSTIKA IGG MICROELISA SYSTEM
K911393
Organon Teknika Corp.
Microbiology · 31d
Cleared Dec 04, 1990
RUBELLA IGM ELISA TEST
K904084
Gull Laboratories, Inc.
Microbiology · 90d
Cleared Dec 04, 1990
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079
Ortho Diagnostic Systems, Inc.
Microbiology · 21d
Cleared Sep 05, 1990
MODIFICATION OF SEROCARD RUBELLA IGG TEST
K902571
Disease Detection International, Inc.
Microbiology · 90d
Cleared Aug 09, 1990
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)
K902925
Vitek Systems, Inc.
Microbiology · 37d
Cleared Jun 28, 1990
RUBELLA IGG ELISA TEST
K901635
Gull Laboratories, Inc.
Microbiology · 80d
Cleared Dec 29, 1989
ORTHO* RUBELLA-G ANTIBODY ELISA TEST
K896479
Ortho Diagnostic Systems, Inc.
Microbiology · 46d
Cleared Dec 21, 1989
PLATELIA RUBELLA IGG KIT
K894946
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 140d