LFZ · Class II · 21 CFR 866.3175

FDA Product Code LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

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

58
Total
58
Cleared
198d
Avg days
1982
Since
58 devices
49–58 of 58
Cleared Apr 11, 1989
CMV-CUBE(TM)
K884842
Difco Laboratories, Inc.
Microbiology · 141d
Cleared Apr 10, 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248
Disease Detection International, Inc.
Microbiology · 181d
Cleared Mar 27, 1989
CYTOMEGALOVIRUS IGG EIA KIT
K880433
De Ferris Laboratories, Inc.
Microbiology · 420d
Cleared Mar 27, 1989
UBI MAGIWEL CMV IGG QUANTITATIVE
K883399
United Biotech, Inc.
Microbiology · 228d
Cleared May 13, 1988
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361
Disease Detection International, Inc.
Microbiology · 134d
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 Aug 08, 1983
CMV RQ BIO-ENZABEAD KIT
K831343
Litton Bionetics
Immunology · 105d
Cleared May 09, 1983
CYTOMEGELISA STAT
K830615
M.A. Bioproducts
Chemistry · 70d
Cleared Dec 28, 1982
CORDIA CMV
K823123
Cordis Corp.
Chemistry · 67d