ClearanceBrief
Panels › Microbiology › Product code LFZ · Class 2

Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Regulation 866.3175

0510(k)s in 12 months (58 all time)
1recalls in 12 months (9 all time)
7recalls that name a 510(k)
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Top companies in LFZ

Company510(k)sRecalls
Abbott Laboratories62
Zeus Scientific, Inc.51
Behring Diagnostics, Inc.50
Gull Laboratories, Inc.40
Roche Diagnostics40
DiaSorin, Inc.30
Incstar Corp.30
Mercia Diagnostics , Ltd.30
BioMerieux SA02
Diagnostic Products Corp.20
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Environmental Pollutants Profile Test
Open, Classified		 LFZNone listed
Dec 6, 2022Bio-Rad Laboratories, Inc.
CMV IgM EIA, in vitro diagnostic.
Open, Classified		 LFZK982485
Feb 14, 2017BioMerieux SA
VIDAS 3 software v. 1.1.4
Terminated		 LFZNone listed
Mar 26, 2015Diamedix Corporation
Diamedix Is-CMV IgG Test Kit
Terminated		 LFZK981163
Apr 15, 2009Abbott Laboratories
AxSYM CMV IgG Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to
Terminated		 LFZK953943
Jul 11, 2007Abbott Laboratories
AxSYM CMV IgG Reagent Pack; list 04B47; 100 test pack; in-vitro diagnostic; Abbott Laboratories, Abbott Park, IL 60064
Terminated		 LFZK953943
Jul 20, 2004bioMerieux
VIDAS CMV IgG Assay
Terminated		 LFZK920661
Aug 12, 2003Zeus Scientific Inc
Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic, manufactured by Zeus Scientific, Inc., Raritan, NJ.
Terminated		 LFZK891081
Aug 12, 2003Meridian Bioscience Inc
Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.
Terminated		 LFZK924096

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