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
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
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 Dec 16, 1999
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952
Diagnostic Products Corp.
Microbiology · 24d
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 Jun 28, 1994
OPUS CMV-G
K933389
Pb Diagnostic Systems, Inc.
Microbiology · 351d
Cleared Apr 08, 1993
BARTELS CYTOMEGALOVIRUS IGG EIA
K922582
Baxter Diagnostics, Inc.
Microbiology · 316d
Cleared Apr 02, 1993
CMV ELISA TEST SYSTEM
K924096
Zeus Scientific, Inc.
Microbiology · 232d

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.