LFZ · Class II · 21 CFR 866.3175

FDA Product Code LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Leading manufacturers include Abbott Laboratories, Zeus Scientific, Inc. and Behring Diagnostics, Inc..

58
Total
58
Cleared
198d
Avg days
1982
Since
58 devices
25–48 of 58
Cleared Feb 12, 1993
VIDAS CMV IGG ASSAY
K920661
Vitek Systems, Inc.
Microbiology · 365d
Cleared Apr 28, 1992
ENZYGNOST(R) ANTI-CMV IGG
K913910
Behring Diagnostics, Inc.
Microbiology · 242d
Cleared Feb 27, 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693
Behring Diagnostics, Inc.
Microbiology · 192d
Cleared Feb 14, 1992
CMV IGG ELISA TEST
K915892
Gull Laboratories, Inc.
Microbiology · 52d
Cleared May 20, 1991
ENZYGNOST ANTI-CMV/IGG + IGM
K901485
Behring Diagnostics, Inc.
Microbiology · 417d
Cleared Dec 17, 1990
CMV IGM ELISA TEST
K903807
Gull Laboratories, Inc.
Microbiology · 119d
Cleared Dec 17, 1990
ORTHO CMV-M ANTIBODY ELISA TEST
K905077
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Dec 17, 1990
ORTHO CMV-G ANTIBODY ELISA TEST
K905078
Ortho Diagnostic Systems, Inc.
Microbiology · 34d
Cleared Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
K900473
Abbott Laboratories
Microbiology · 176d
Cleared Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
K900474
Abbott Laboratories
Microbiology · 176d
Cleared May 02, 1990
CMV IGG ELISA TEST
K900796
Gull Laboratories, Inc.
Microbiology · 71d
Cleared Feb 27, 1990
CMV IGM ELISA TEST SYSTEM
K896355
Zeus Scientific, Inc.
Microbiology · 113d
Cleared Dec 18, 1989
DETECTADOT TM SYSTEM 2000 CMV IGM TEST
K893230
Gull Laboratories, Inc.
Microbiology · 234d
Cleared Jun 23, 1989
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610
Organon Teknika Corp.
Microbiology · 136d
Cleared Jun 02, 1989
CMV ELISA TEST SYSTEM
K891081
Zeus Scientific, Inc.
Microbiology · 93d
Cleared Apr 11, 1989
CMV-CUBE(TM)
K884842
Difco Laboratories, Inc.
Microbiology · 141d
Cleared Sep 16, 1985
ENZYGNOST + ANTI-CMV IGG TEST
K852478
Behring Diagnostics, Inc.
Microbiology · 97d
Cleared Oct 27, 1983
YBBOTT CMV TOTAL AB EIA
K832221
Abbott Laboratories
Microbiology · 111d
Cleared Dec 28, 1982
CORDIA CMV
K823123
Cordis Corp.
Chemistry · 67d