ClearanceBrief
Panels › Microbiology › Product code MKZ · Class 1

Dna Probe, Nucleic Acid Amplification, Chlamydia

Regulation 866.3120

0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
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Top companies in MKZ

Company510(k)sRecalls
Becton, Dickinson & CO42
Roche Molecular Systems, Inc.51
Gen-Probe, Inc.50
Roche Diagnostics Corp.20
Abbott Laboratories10
Abbott Molecular, Inc.10
Hologic, Inc.10
DateFirm and productCodeLinked 510(k)
Jun 24, 2011Becton Dickinson & Co.
BD ProbeTec" CT/GC/AC Reagent Pack, catalog #440450, labeled in part ***Becton Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152*** The BD ProbeTec" ET Chlamydia trachomatis and Neisseria go
Terminated		 MKZK984631
Mar 3, 2010Becton Dickinson & Co.
BD Probetec" ET CT/GC Endocervical Specimen Collection and Dry Transport System-Pink Cap, Catalog number 440476, packed in shelfpack unit of 100 swabs.
Terminated		 MKZNone listed
Aug 19, 2004Roche Molecular Systems Inc
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG CT Detection Kit
Terminated		 MKZK973707

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