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Panels › Microbiology › Product code LFY · Class 2

Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Regulation 866.3900

0510(k)s in 12 months (17 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
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Top companies in LFY

Company510(k)sRecalls
DiaSorin, Inc.31
Zeus Scientific, Inc.40
Biomerieux Inc02
Diamedix Corp.20
Biomerieux Vitek, Inc.10
Bionetic Laboratory Products10
Biowhittaker Molecular Applications, Inc.10
Calbiotech Inc01
Clinical Sciences, Inc.10
Gull Laboratories, Inc.10
DateFirm and productCodeLinked 510(k)
Jan 4, 2023Biomerieux Inc
VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
Open, Classified		 LFYK923122
Dec 10, 2019bioMerieux, Inc.
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Terminated		 LFYK923122
Mar 5, 2010Calbiotech Inc
VZV IgG ELISA 96 Well Kit, Catalog Number: VZ081G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Terminated		 LFYNone listed
Mar 8, 2005Diasorin Inc.
Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285
Terminated		 LFYK900688

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