Panels › Immunology › Product code NQI · Class 2
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Regulation 866.6020
0510(k)s in 12 months (13 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Top companies in NQI
| Company | 510(k)s | Recalls |
|---|---|---|
| Veridex, LLC | 10 | 7 |
| Immunicon Corp. | 2 | 0 |
| Menarini Silicon Biosystems | 0 | 2 |
| Advanced Diagnostic Systems | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2022 | Menarini Silicon Biosystems CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole Open, Classified |
NQI | K103502 |
| Apr 4, 2018 | Menarini Silicon Biosystems CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001)
CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD Terminated |
NQI | K103502 |
| 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 |
| Feb 23, 2010 | Veridex, LLC CellSearch Circulating Tumor Cell Kit (Epithelial) IVD
REF 7900001
Veridex LLC, a Johnson & Johnson Company. Terminated |
NQI | K073338 |
| 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 |
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