Company ยท US
Veridex, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2013. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2013 | K130794 | CELLTRACKS ANALYZER II SYSTEM Veridex, LLC | NQI |
| Dec 13, 2012 | K122821 | CELLTRACKS AUTOPREP SYSTEM Veridex, LLC | NQI |
| Jan 20, 2012 | K110406 | CELLTRACKS AUTOPREP SYSTEM Veridex, LLC | NQI |
| Dec 12, 2011 | K113181 | CELLTRACKS ANALYER II Veridex, LLC | NQI |
| Dec 21, 2010 | K103502 | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 Veridex, LLC | NQI |
| Aug 26, 2010 | K100684 | CELLTRACKS AUTOPREP SYSTEM MODEL:9541 Veridex, LLC | GKH |
| Feb 26, 2008 | K073338 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Nov 20, 2007 | K071729 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Dec 14, 2006 | K062013 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Oct 27, 2005 | K052191 | MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Mar 15, 2005 | K050245 | CELLSEARCH CIRCULATING TUMOR CELL KIT Veridex, LLC | NQI |
| Jun 28, 2004 | K040898 | CELLSEARCH EPITHELIAL CELL CONTROL KIT Veridex, LLC | NRS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2015 | Veridex, LLC Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood. Terminated |
NQI | K103502 |
| Mar 13, 2014 | Veridex, LLC CELLTRACKS ANALYZER II (Product Code 9555)
Product Usage:
The CELLTRACKS ANALYZER II is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS sof Terminated |
NQI | K050145 K130794 |
| Aug 10, 2013 | Veridex, LLC CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below.
Product Usage:
The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and e Terminated |
NQI | K110406 K122821 |
| Aug 10, 2013 | Veridex, LLC CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below.
Product Usage:
The CELLTRACKS AUTOPREP System is a general purpose laboratory instrument used with immunomagnetic reagents that capture a Terminated |
NQI | K110406 K122821 |
| Feb 13, 2012 | Veridex, LLC CellTracks Analyzer II.
A semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immuno-magnetically selected and aligned. The system is for in-vitro diagnostic Terminated |
NQI | K050145 K060110 +1 |
| Mar 1, 2011 | Veridex, LLC Veridex, Cell Search Circulating Tumor Cell Control Kit. Product code 7900003 Terminated |
NRS | K040898 |
| Aug 5, 2010 | Veridex, LLC CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD
Veridex, LLC
a Johnson & Johnson Company
Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in Terminated |
GKH | K040077 |
| Feb 23, 2010 | Veridex, LLC CellSearch Circulating Tumor Cell Kit (Epithelial) IVD
REF 7900001
Veridex LLC, a Johnson & Johnson Company. Terminated |
NQI | K073338 |
| Aug 13, 2009 | Veridex, LLC CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater. Distributed by Veridex, 33 Technology Drive, Warren, NJ 07059. Manufactured by Immunicon, Huntingdon Valley, Terminated |
GKH | K040077 |
| Jul 24, 2007 | Veridex, LLC Cell Search Circulating Tumor Cell Kit (Epithelial)
Veridex LLC, a Johnson & Johnson Company
IVD
Veridex, LLC
33 Technology Drive
Warren, NJ 07059 USA
1-877-VERIDEX USA Terminated |
NQI | K050245 K052191 +1 |