FDA Product Code LFZ: Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Leading manufacturers include Abbott Laboratories, Roche Diagnostics and Diagnostic Products Corp..
58
Total
58
Cleared
198d
Avg days
1982
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Devices (Product Code LFZ)
58 devices
Cleared
Oct 27, 2022
Architect CMV IgG
Abbott Laboratories
Microbiology
209d
Cleared
Oct 12, 2022
Elecsys CMV IgG
Roche Diagnostics
Microbiology
197d
Cleared
Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
Siemens Healthcare Diagnostics, Inc.
Microbiology
84d
Cleared
Mar 17, 2017
Elecsys CMV IgM
Roche Diagnostics
Microbiology
88d
Cleared
Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
Diagnostic Products Corp.
Microbiology
24d
Cleared
Mar 24, 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
Abbott Laboratories
Microbiology
579d
Cleared
Sep 20, 1996
AXSYM CMV IGG ANTIBODY ASSAY
Abbott Laboratories
Microbiology
396d
Cleared
Jun 17, 1996
IMMULITE CMV IGG
Diagnostic Products Corp.
Microbiology
490d
Cleared
Jul 27, 1990
IMX CMV IGM ANTIBODY ASSAY
Abbott Laboratories
Microbiology
176d
Cleared
Jul 27, 1990
IMX CMV IGG ANTIBODY ASSAY
Abbott Laboratories
Microbiology
176d
Cleared
Oct 27, 1983
YBBOTT CMV TOTAL AB EIA
Abbott Laboratories
Microbiology
111d
Cleared
Dec 28, 1982
CORDIA CMV
Cordis Corp.
Chemistry
67d
About Product Code LFZ - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code LFZ since 1982, with 58 receiving FDA clearance (average review time: 198 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.