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
73–94 of 94
Cleared Jul 14, 1986
RUBELLA ELISA TEST SYSTEM CATALOG NUMBER: 4540
K860145
Clinical Sciences, Inc.
Microbiology · 180d
Cleared Jun 17, 1986
RUBELLA IGG EIA TEST KIT
K853696
Labsystems, Inc.
Microbiology · 285d
Cleared May 01, 1986
CORDOT R
K854618
Cordis Corp.
Microbiology · 164d
Cleared Jan 01, 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069
Hybritech, Inc.
Microbiology · 163d
Cleared May 21, 1984
RUBELLA IGG ANTIBODY ELISA TEST SYS
K841200
Ortho Diagnostic Systems, Inc.
Microbiology · 61d
Cleared Mar 17, 1983
ORTHO RUBELLA ELISA TEST SYSTEM
K822342
Ortho Diagnostic Systems, Inc.
Microbiology · 225d
Cleared Mar 04, 1982
ENZYGNOST TM RUBELLA IGM
K813493
Calbiochem-Behring Corp.
Immunology · 80d
Cleared Nov 16, 1979
ROTAZYME
K791746
Abbott Laboratories
Microbiology · 67d