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Nov 15, 2007 . The FDA-approved CellSearch System is the first diagnostic test to automatically
Circulating tumor cells have been part of the cancer dialogue since the mid-
The performance characteristics and safety and effectiveness have not been
שלושה מעצבים - בניית אתרים באינטרנט. CELLSEARCH FDA APPROVAL - Page 6.
Feb 15, 2011 . made to the prior device, was approved. In October 2005, a modification to the
FDA Clears Cellsearch(TM) Circulating Tumor Cell Test for Monitoring . so
Abstract. The presence of rare Circulating Tumor Cells (CTCs) in the peripheral
significant higher CTCs capturing rate compared to the FDA-approved
The CellSearch System has also been FDA approved for breast and colon
Jun 29, 2011 . The US Food and Drug Administration (FDA) approved CellSearch for clinical
Immunicon Corporation (NASDAQ: IMMC) announced that the FDA CellSearch
Warning: set_time_limit() [function.set-time-limit]: Cannot set time limit in safe
Dec 23, 2006 . Veridex Receives FDA Approval for Breast Cancer Test Kit . has received FDA
Mar 1, 2008 . US Food and Drug Administration (FDA) has granted an expanded clearance for
Feb 10, 2009 . The Cellsearch ™ test first received FDA approval in January 2004 as a
The CellSearch™ Circulating Tumour Cell Kit is FDA approved for in vitro
Most technologies for CTC detection, including the FDA-approved CellSearch,
May 28, 2008 . In 2004, CellSearch was approved for detecting and counting CTCs in metastatic
Over the last year, Drs. Gilewski and Ragupathi have gained experience with the
Enumeration of CTCs by CellSearch is FDA approved, highly reproducible and
The CellSearch System has also been FDA approved for breast and colon
May 26, 2011 . Veridex Receives FDA Approval For Breast Cancer Test Kit . has received FDA
Jan 17, 2010 . Veridex Receives FDA Approval For Breast Cancer Test Kit - News . received
Clinical Utility: CellSearch is an FDA-approved test intended for the enumeration
Nov 1, 2011 . CellSearch is approved by FDA for metastatic breast, colorectal and prostate
May 1, 2012 . CellSearch, a FDA-approved in vitro diagnostic device for serial monitoring of
In 2004, the US FDA approved CellSearch, an epithelial cell analyzer kit to detect
The system is CellSearch, developed and marketed by Veridex, a division of
Feb 29, 2008 . The CellSearch™ System was originally cleared by the FDA in . . done earlier
Jun 30, 2009 . CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer - K031588.www.fda.gov/. /DeviceApprovalsandClearances/. ApprovedDevices/ ucm081239.htm - Cached - Similar-/é DEPARTMENT OF HEALTH 81 HUMAN SERVICES - FDACellSearch Epithelial Cell Kit/Cell Spotter Analyzer . Regulation . These devices
CellSearch® (Veridex, Warren, NJ). – Currently the only FDA approved method
Mar 7, 2008 . The CellSearch Circulating Tumor Cell (CTC) Kit has received an expanded
The CellSearch assay is FDA approved in the United States as a prognostic test
Dec 15, 2009 . HER2 status of CTCs was assessed using both the FDA approved CellSearch©
Feb 28, 2008. nation to offer a new, FDA-approved test that will aid in the treatment of . The
Veridex Receives FDA Approval For Breast Cancer Test Kit . subsidiary Veridex
The CellSearch test is the only FDA approved test for CTC assessment. Each
Jan 13, 2011 . Device Approvals and Clearances . . 510(k) SUMMARY AVAILABLE FROM
The FDA-approved Veridex LLC CellSearch Circulating Tumor Cell Kit is
Feb 14, 2011 . Veridex, marketer of the only FDA-approved CTC test, launched its CTC
characterization at both cellular and sub-cellular level, cytometric methods are
At the time this LCD was written and published the Cell Search (Veridex )
Jan 18, 2012 . Clin Cancer Res 2008;(19) 6302-6309) that actually led to the CellSearch FDA
Comparison with FDA approved CellSearch. • CCF. – Comparison with FDA
Feb 10, 2007 . The CellSearch Circulating Tumor Cell Kit has received FDA approval as an aid
The Veridex Johnson & Johnson CellSearch System includes the CellSearch
Jan 28, 2010 . CellSearch, (manufactured by Veridex, LLC), is the first automated, FDA-
The CellSearch system entered the U.S. healthcare market in January 2004
Apr 23, 2012 . PCR; CellSearch® - Sole FDA-approved technique for CTC enumeration - Ficoll
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