LFX · Class II · 21 CFR 866.3510

FDA Product Code LFX: Enzyme Linked Immunoabsorbent Assay, Rubella

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

94
Total
94
Cleared
172d
Avg days
1979
Since
94 devices
49–72 of 94
Cleared Jun 23, 1989
IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY
K885295
Abbott Laboratories
Microbiology · 178d
Cleared Jun 23, 1989
IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY
K885297
Abbott Laboratories
Microbiology · 178d
Cleared Jun 08, 1989
RUBELLA-CUBE(TM)
K892051
Difco Laboratories, Inc.
Microbiology · 71d
Cleared Feb 02, 1989
ORTHO RESULT PLUS/RUBELLA RAPID COLOR. IMMUNOASSAY
K884617
Ortho Diagnostic Systems, Inc.
Microbiology · 90d
Cleared Jan 31, 1989
RUBENOSTIKA(TM) IGM MICROELISA SYSTEM
K882999
Organon Teknika Corp.
Microbiology · 197d
Cleared Oct 25, 1988
RUBELLA IGM MICROASSAY
K883778
Diamedix Corp.
Microbiology · 49d
Cleared Oct 06, 1988
AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200
K882475
Amersham Corp.
Microbiology · 113d
Cleared Sep 09, 1987
VIRGO(TM) RUBELLA IGG ELISA
K873088
Electro-Nucleonics Laboratories, Inc.
Microbiology · 35d
Cleared Apr 14, 1987
RUBELLA MICROASSAY
K864602
Diamedix Corp.
Microbiology · 141d
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