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Panels › Immunology › Product code LLL · Class 2

Extractable Antinuclear Antibody, Antigen And Control

Regulation 866.5100

2510(k)s in 12 months (182 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
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Top companies in LLL

Company510(k)sRecalls
Inova Diagnostics, Inc.370
Hemagen Diagnostics, Inc.160
Diamedix Corp.102
Hycor Biomedical, Inc.100
Immuno Concepts, Inc.81
Zeus Scientific90
Advanced Biological Products, Inc.80
Immco Diagnostics, Inc.80
Cogent Diagnotics , Ltd.70
Helix Diagnostics, Inc.60
DateFirm and productCodeLinked 510(k)
Aug 6, 2012Diamedix Corporation
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm ant
Terminated		 LLLK970220
May 21, 2012Diamedix Corporation
Product is labeled in part: "***is immunosimplicity***ENA-6 Screen***Enzyme Immunoassay Test Kit***Catalog No: 720-230***Exp. Date: 2012-05-31***Contains Sufficient for 96 Tests***C - Corrosive Harmf
Terminated		 LLLK980759
Apr 6, 2009Immuno Concepts Inc
RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system, manufactured by Immuno Concepts N.A. Ltd., Sacramento, CA.
Terminated		 LLLK935129
Apr 6, 2005Diasorin Inc.
Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
Terminated		 LLLK944505

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