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Panels › Microbiology › Product code LJC · Class 1

Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Regulation 866.3120

0510(k)s in 12 months (67 all time)
1recalls in 12 months (7 all time)
4recalls that name a 510(k)
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Top companies in LJC

Company510(k)sRecalls
Abbott Laboratories100
Syva Co.70
Eastman Kodak Company40
Kallestad Diag, A Div. of Erbamont, Inc.40
Ortho Diagnostic Systems, Inc.40
Bio-Rad Laboratories, Inc.30
Boots-Celltech Diagnostics, Inc.30
Ciba Corning Diagnostics Corp.30
Quidel Corp.30
Thermo Biostar, Inc.12
DateFirm and productCodeLinked 510(k)
Dec 1, 2025GET TESTED INTERNATIONAL AB
Chlamydia Test
Open, Classified		 LJCNone listed
Sep 2, 2011bioMerieux, Inc.
VIDAS Chlamydia test kits VIDAS Chlamydia is an automated qualitative test for use on the VIDAS family instruments, for the detection of Chlamydia antigen in endocervical or urethral specimens, using
Terminated		 LJCK905787
Mar 5, 2010Calbiotech Inc
Chlamydia Pneumoniae IgM ELISA 96 Well Kit, Catalog Number: CP095M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Terminated		 LJCNone listed
Mar 5, 2010Calbiotech Inc
Chlamydia Pneumoniae IgG ELISA 96 Well Kit, Catalog Number: CP083G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
Terminated		 LJCNone listed
Oct 15, 2003bioMerieux
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
Terminated		 LJCK915884
Mar 6, 2003Thermo Biostar, Incorporated
Chlamydia OIA. For in vitro diagnostic use.
Terminated		 LJCK951010
Mar 6, 2003Thermo Biostar, Incorporated
Chlamydia OIA. For in vitro diagnostic use,
Terminated		 LJCK951010

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