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
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Devices (Product Code LFZ)

58 devices
1–24 of 58
Cleared Oct 27, 2022
Architect CMV IgG
K220949
Abbott Laboratories
Microbiology · 209d
Cleared Oct 12, 2022
Elecsys CMV IgG
K220911
Roche Diagnostics
Microbiology · 197d
Cleared Jul 30, 2018
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Mar 17, 2017
Elecsys CMV IgM
K163569
Roche Diagnostics
Microbiology · 88d
Cleared Jan 06, 2017
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
K162969
DiaSorin, Inc.
Microbiology · 74d
Cleared Oct 24, 2014
ELECYS CMV IGM IMMUNOASSAY
K142133
Roche Diagnostics
Microbiology · 81d
Cleared Feb 28, 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605
Roche Diagnostics
Microbiology · 270d
Cleared Jun 01, 2005
DIASORIN LIAISON CMV IGM/IGG
K040290
Diasorin S.P.A
Microbiology · 481d
Cleared Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952
Diagnostic Products Corp.
Microbiology · 24d
Cleared Jan 13, 1999
SERAQUEST CMV IGM
K982485
Quest Intl., Inc.
Microbiology · 180d
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K984139
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Dec 14, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983803
Zeus Scientific, Inc.
Microbiology · 47d
Cleared Nov 25, 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
K982027
DiaSorin, Inc.
Microbiology · 176d
Cleared Sep 21, 1998
DIAMEDIX IS-CMV IGG TEST SYSTEM
K981163
Diamedix Corp.
Microbiology · 174d
Cleared Dec 01, 1997
QUANTA LITE CMV IGG ELISA
K971335
Inova Diagnostics, Inc.
Microbiology · 235d
Cleared Mar 24, 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301
Abbott Laboratories
Microbiology · 579d
Cleared Feb 20, 1997
HEMAGEN CMV IGG KIT
K944438
Hemagen Diagnostics, Inc.
Microbiology · 892d
Cleared Oct 17, 1996
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434
Incstar Corp.
Microbiology · 260d
Cleared Oct 09, 1996
OPUS CMV TEST SYSTEM-MODIFICATION
K963084
Behring Diagnostics, Inc.
Microbiology · 62d
Cleared Sep 20, 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943
Abbott Laboratories
Microbiology · 396d
Cleared Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
K955360
Incstar Corp.
Microbiology · 243d
Cleared Jul 22, 1996
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361
Incstar Corp.
Microbiology · 243d
Cleared Jun 17, 1996
IMMULITE CMV IGG
K950672
Diagnostic Products Corp.
Microbiology · 490d
Cleared Feb 23, 1996
SERAQUEST CMV IGG
K954191
Quest Intl., Inc.
Microbiology · 170d

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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.